Data / Medical devices / United States / Medical Components Inc
Medical Components Inc: FDA-registered device maker in Harleysville, PA, United States, 113 510(k) clearances
Medical Components Inc is registered with the FDA (registration 2518902) in Harleysville, PA, United States. It lists 34 device types. The FDA files 113 510(k) clearances under its listings, the newest dated October 9, 2026. 23 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2518902
- Address
- 1499 Delp Drive, Harleysville, PA, United States, 19438
- Owner or operator
- Medical Components Inc (2518902)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- November 17, 1992
- Registered through
- 2026
- Brand names listed
- 20G X 3/4" Pro-Lock Safety Infusion Set, Catheter Extension Repair Clamps, Duralock, Pro-PICC(R) CT, Symetrex LTHD Catheter and Symetrex LTHD Catheter with Sideholes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, A-V Shunt | KNZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Femoral | LFK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Hemodialysis, Implanted | MSD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Hemodialysis, Non-Implanted | MPB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Infusion | JCY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Subclavian | LFJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ventricular, General & Plastic Surgery | GBS | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Graft, Vascular, Stainless Steel Tunneler | MZY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Kit, Repair, Catheter, Hemodialysis | NFK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Midline Catheter | PND | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Non-Coring (Huber) Needle | PTI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer for export | accessdata.fda.gov |
| Trocar | DRC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 113.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2026 | K260080 | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| August 12, 2025 | K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | MPB | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| November 16, 2023 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | NIE | Unknown | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| September 14, 2021 | K210461 | End Cap | MSD | Substantially Equivalent | Medical Components Inc (Medcomp) | accessdata.fda.gov |
| April 7, 2021 | K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | PTI | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| September 3, 2020 | K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | MSD | Substantially Equivalent | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| April 23, 2020 | K192807 | Duo-Flow Side x Side Double Lumen Catheter | MPB | Substantially Equivalent | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| June 14, 2019 | K183219 | Trio-CT Triple Lumen Catheter | NIE | Unknown | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| November 21, 2018 | K180546 | Jet Power Injectable PICC | LJS | Substantially Equivalent | Jet Medical, Inc. | accessdata.fda.gov |
| July 5, 2018 | K181175 | 12F Tri-Flow Triple Lumen Catheter | NIE | Unknown | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| October 26, 2017 | K171931 | Celerity ECG Cable Accessory Pack | LJS | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| July 25, 2017 | K170770 | CT Midline | PND | Substantially Equivalent | Medical Components, Inc. (dba MedComp) | accessdata.fda.gov |
| June 1, 2017 | K162389 | Medcomp Vessel Dilator | DRE | Substantially Equivalent | Medcomp ( Medical Components) | accessdata.fda.gov |
| April 26, 2017 | K162271 | Pro-Lock CT Safety Infusion Set | PTI | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| February 2, 2017 | K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 15, 2016 | K153238 | Dignity Dual Port | LJT | Substantially Equivalent | Medcomp ( Medical Components) | accessdata.fda.gov |
| February 12, 2016 | K153246 | PTFE Super Sheath Introducer 2.1 | DYB | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| January 27, 2015 | K142889 | Celerity PICC Tip Confirmation System | LJS | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| November 26, 2014 | K140884 | SYMETREX LONG TERM HEMODIALYSIS CATHETER | MSD | Unknown | Phase One Medical | accessdata.fda.gov |
| September 29, 2014 | K141633 | PRO-PICC WITH VALVE TECHNOLOGY | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141151 | CT MIDLINE | LJS | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| June 13, 2014 | K140799 | CELERITY SYSYEM | LJS | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| April 28, 2014 | K130889 | SPLIT CATH RG | MSD | Unknown | Medcomp | accessdata.fda.gov |
| January 8, 2014 | K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | FPA | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| December 12, 2013 | K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | LJT | Substantially Equivalent | Medcomp ( Medical Components) | accessdata.fda.gov |
| November 25, 2013 | K132498 | VALVED TEARAWAY INTRODUCER GENERATION II | DYB | Substantially Equivalent | Medcomp (Medical Components, Inc.) | accessdata.fda.gov |
| October 22, 2013 | K130897 | MEDCOMP VASCU-PICC WITH VALVE | LJS | Substantially Equivalent | Medcomp ( Medical Components) | accessdata.fda.gov |
| August 16, 2013 | K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| August 15, 2013 | K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | DYB | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| July 31, 2013 | K130923 | 5F DIGNITY CT TITANIUM PORT | LJT | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| July 29, 2013 | K130855 | PTFE SUPER SHEATH INTRODUCER | DYB | Substantially Equivalent | Martech Medical Products | accessdata.fda.gov |
| June 11, 2013 | K123292 | T3 | NIE | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| June 3, 2013 | K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | DYB | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| May 15, 2013 | K123617 | 3F PRO-PICC | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| December 12, 2012 | K122423 | VASU-PICC | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| November 19, 2012 | K120617 | PTFE SUPER SHEATH INTRODUCER | DYB | Substantially Equivalent | Martech Medical Products | accessdata.fda.gov |
| September 21, 2012 | K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | MSD | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| September 17, 2012 | K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | LJT | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| September 5, 2012 | K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | FJS | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| June 6, 2012 | K121094 | MEDCOMP VASCU-PICC & MIDLINE CATHETERS | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| May 2, 2012 | K120981 | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| May 2, 2012 | K120980 | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| March 9, 2012 | K113487 | HEMO-CATH 10F, HEMO-CATH 12.5F | MSD | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| December 8, 2011 | K111651 | SPLIT CATH III | MSD | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| November 30, 2011 | K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL | LJT | Substantially Equivalent | Medcomp ( Medical Components) | accessdata.fda.gov |
| December 21, 2010 | K102966 | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| January 8, 2010 | K091954 | MICRO-STICK SET | DYB | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| November 24, 2009 | K093309 | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 | LJS | Substantially Equivalent | Medcomp ( Medical Components) | accessdata.fda.gov |
| September 16, 2009 | K092347 | PRO-PICC CT | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| September 16, 2009 | K091953 | PRO-PICC | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| September 1, 2009 | K090394 | VALVED TEARWAY INTRODUCER | DYB | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| July 23, 2009 | K091586 | VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| June 17, 2009 | K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| March 25, 2009 | K081775 | THE MEDCOMP .010 VASCULAR GUIDEWIRES | DQX | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| September 23, 2008 | K081904 | PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| August 14, 2008 | K080544 | UNASSIGNED | FPA | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| November 26, 2007 | K072509 | PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| May 15, 2007 | K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) | LJT | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| February 15, 2007 | K070150 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| August 3, 2006 | K061986 | 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| August 1, 2006 | K053092 | MEDCOMP VASCU-SHEATH II | DYB | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| March 17, 2006 | K053345 | PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| November 30, 2005 | K051280 | MEDCOMP SPLIT CATH II | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| March 1, 2005 | K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| February 3, 2005 | K040318 | MEDCOMP SPLIT-CATH II | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| November 24, 2004 | K040328 | 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| September 16, 2004 | K033570 | MEDCOMP T-3 | NIE | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| July 29, 2004 | K040992 | 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 | MSD | Unknown | Medcomp | accessdata.fda.gov |
| September 30, 2003 | K031652 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| June 5, 2003 | K030636 | C-PORT | LJT | Substantially Equivalent | Clinisurg Vascular Products, LLC | accessdata.fda.gov |
| May 20, 2003 | K030502 | 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| April 11, 2003 | K030270 | 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| February 24, 2003 | K022678 | MEDCOMP SC4 | MSD | Unknown | Medcomp | accessdata.fda.gov |
| October 31, 2002 | K022570 | MEDCOMP REPAIR KIT, MODEL ASPCRPK | NFK | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| October 25, 2002 | K022513 | MEDCOMP VASCU-SHEATH INTRODUCER SET | DYB | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| October 11, 2002 | K020936 | 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL | MSD | Unknown | Medcomp | accessdata.fda.gov |
| July 18, 2002 | K021990 | GALT MEDICAL GUIDEWIRE | DQX | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| May 24, 2002 | K020315 | 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL | MSD | Unknown | Medcomp | accessdata.fda.gov |
| May 22, 2002 | K020465 | MEDCOMP ASH SPLIT-CATH II | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| February 8, 2002 | K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| October 19, 2001 | K013162 | 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH | KNT | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| October 3, 2001 | K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | MSD | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| October 3, 2001 | K010306 | MEDCOMP EXCELL SPLIT TIP CATHETER | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| June 21, 2001 | K011576 | MEDCOMP ASH SPLIT | NFK | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| February 23, 2001 | K010021 | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S | FOZ | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| January 26, 2001 | K003682 | MEDCOMP Z-CATH | LJS | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| December 1, 2000 | K003110 | MEDCOMP BIO-CATH CATHETER LINE | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| June 10, 1999 | K980438 | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT | MPB | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| June 8, 1999 | K983511 | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH | MPB | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| April 15, 1999 | K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB | MPB | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| February 26, 1999 | K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 | MSD | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| May 11, 1998 | K973561 | MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M | FOZ | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| February 23, 1998 | K972207 | MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| February 23, 1998 | K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) | MSD | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
| October 9, 1997 | K971281 | RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE | DQX | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| September 25, 1995 | K923691 | TWIN SILICONE CATHETER | MPB | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| February 2, 1994 | K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS | FJS | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| February 2, 1993 | K915423 | HEMO-CATH SILICONE ACCESS CATHETER | LFJ | Unknown | Medical Components, Inc. | accessdata.fda.gov |
| June 13, 1989 | K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C | LFJ | Substantially Equivalent | Medical Components, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 13, 2021 | 87265 | Class II | Ongoing | Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. | The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obta | accessdata.fda.gov |
| July 27, 2020 | 86163 | Class II | Terminated | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 | Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer | accessdata.fda.gov |
| March 13, 2019 | 83324 | Class II | Terminated | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. | accessdata.fda.gov |
| March 13, 2019 | 82415 | Class II | Terminated | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. | accessdata.fda.gov |
| October 1, 2018 | 81439 | Class II | Terminated | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement. | accessdata.fda.gov |
| July 12, 2018 | 80581 | Class II | Terminated | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108 | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. | accessdata.fda.gov |
| February 23, 2018 | 79436 | Class II | Terminated | CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. | accessdata.fda.gov |
| November 22, 2017 | 79445 | Class II | Terminated | 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter | The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire. | accessdata.fda.gov |
| May 25, 2017 | 78221 | Class II | Terminated | 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular sy | The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip. | accessdata.fda.gov |
| February 23, 2017 | 76625 | Class II | Terminated | 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port sy | The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure. | accessdata.fda.gov |
| May 5, 2016 | 74176 | Class II | Terminated | Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is i | This recall has been initiated due to the product labeled with the incorrect expiration date. | accessdata.fda.gov |
| February 5, 2015 | 70472 | Class II | Terminated | Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affec | Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification. | accessdata.fda.gov |
| January 28, 2015 | 70457 | Class II | Terminated | 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular acc | The dual port with catheters was not covered under FDA clearance. | accessdata.fda.gov |
| January 21, 2015 | 70351 | Class II | Terminated | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), M | Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported. | accessdata.fda.gov |
| August 4, 2014 | 68993 | Class II | Terminated | Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. | accessdata.fda.gov |
| December 13, 2012 | 64235 | Class II | Terminated | REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits | The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. | accessdata.fda.gov |
| April 12, 2012 | 61860 | Not yet classified | Terminated | 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid | 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port. | accessdata.fda.gov |
| April 2, 2012 | 62238 | Class II | Terminated | MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit. | Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. | accessdata.fda.gov |
| May 19, 2011 | 58975 | Not yet classified | Terminated | THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit | Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer. | accessdata.fda.gov |
| July 2, 2010 | 56225 | Not yet classified | Terminated | medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841. | Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port. | accessdata.fda.gov |
| September 2, 2009 | 53136 | Not yet classified | Terminated | Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits. | mislabeled as right are actually left | accessdata.fda.gov |
| April 11, 2008 | 47856 | Not yet classified | Terminated | CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices | kit contains incorrect component | accessdata.fda.gov |
| September 15, 2005 | 33789 | Not yet classified | Terminated | Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T | The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F | accessdata.fda.gov |
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Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.