Data / Medical devices / United States / Medical Components, Inc.
Medical Components, Inc.: FDA-registered device maker in Yuma, AZ, United States, 7 510(k) clearances
Medical Components, Inc. is registered with the FDA (registration 3013750125) in Yuma, AZ, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 16, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013750125
- Address
- 3088 East 33rd Place, Yuma, AZ, United States, 85365
- Owner or operator
- Medical Components Inc (2518902)
- Roles
- Repackager or relabeler
- First device listed
- March 21, 2008
- Registered through
- 2026
- Brand names listed
- Pro-PICC(R) CT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Hemodialysis, Implanted | MSD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Repackager or relabeler | 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2009 | K091953 | PRO-PICC | LJS | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| November 30, 2005 | K051280 | MEDCOMP SPLIT CATH II | MSD | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| June 5, 2003 | K030636 | C-PORT | LJT | Substantially Equivalent | Clinisurg Vascular Products, LLC | accessdata.fda.gov |
| February 8, 2002 | K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Medical Components, Inc. | 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 |
| July 11, 1985 | K851834 | MANAN GWI GUIDE WIRE INTRODUCER | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| June 14, 1977 | K770977 | CARDIOVASCULAR SPRING GUIDES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Hemodialysis, Implanted
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- All makers of Instruments, Surgical, Cardiovascular
- All makers of Wire, Guide, Catheter
- All makers of Port & Catheter, Implanted, Subcutaneous, Intravascular
Updated September 16, 2009. 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.