Data / Medical devices / United States / Terumo Medical Corp.
Terumo Medical Corp.: FDA-registered device maker in Elkton, MD, United States, 19 510(k) clearances and 1 PMA approval
Terumo Medical Corp. is registered with the FDA (registration 1118880) in Elkton, MD, United States. It lists 8 device types. The FDA files 19 510(k) clearances and 1 PMA approval under its listings, the newest dated July 27, 2023. 11 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1118880
- Address
- 950 Elkton BLVD., Elkton, MD, United States, 21921
- Owner or operator
- TERUMO MEDICAL CORP. (9003933)
- Roles
- Complaint file establishment, Contract sterilizer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- April 15, 1996
- Registered through
- 2027
- Brand names listed
- Angio-Seal, Angio-Seal VIP Vascular Closure Device, Assistant Attachment with StableSoft Technology, Assistant Flex Attachment with StableSoft Technology, CDI Shunt Sensor, Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath, Glidesheath, Glidesheath Slender and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Device, Hemostasis, Vascular | MGB | 3 | Complaint file establishment, Contract sterilizer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | 2 | Contract sterilizer | accessdata.fda.gov |
| Stabilizer, Heart | MWS | 1 | Contract sterilizer | 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 |
|---|---|---|---|---|---|---|
| July 27, 2023 | K231044 | R2P Navicross | DQY | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| December 20, 2021 | K213531 | TR BAND Radial Compression Device | DXC | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| January 6, 2020 | K193125 | R2P Destination Slender Guiding Sheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| December 3, 2019 | K193160 | Glidesheath Slender Tibial Pedal Kit | DYB | Substantially Equivalent | Terumo Medical Coporation | accessdata.fda.gov |
| May 8, 2018 | K173831 | Glidesheath Slender | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| November 21, 2017 | K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| October 5, 2017 | K171491 | R2P Destination Slender Guiding Sheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| January 27, 2017 | K162427 | Vado Bi-Directional Steerable Sheath | DYB | Substantially Equivalent | Kalila Medical, Inc. | accessdata.fda.gov |
| December 1, 2015 | K152173 | Glidesheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| November 10, 2015 | K152525 | TR BAND Radial Compression Device | DXC | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| October 3, 2011 | K111606 | PINNACLE PRECISION ACCESS SYSTEM | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| October 29, 2008 | K082847 | PINNACLE ROII INTRODUCER SHEATH | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| October 23, 2006 | K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| May 10, 2001 | K011084 | MANDREL GUIDEWIRE ASSEMBLY | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| November 21, 2000 | K003424 | PINNACLE R/O II OR RADIFOCUS INTRODUCER II | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| June 28, 1999 | K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET | DYB | Substantially Equivalent | Medamicus, Inc. | accessdata.fda.gov |
| November 27, 1995 | K954234 | RADIFOCUS INTRODUCER II KIT | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| November 20, 1986 | K863138 | TERUMO RADIFOCUS GUIDE WIRE | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| July 11, 1985 | K851834 | MANAN GWI GUIDE WIRE INTRODUCER | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 30, 1996 | P930038 | Angio Seal Vascular Closure Device | MGB | 99 | August 4, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 15, 2026 | 99285 | Class II | Ongoing | GLIDESHEATH SLENDER A-KIT 6F 10CM.021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. | accessdata.fda.gov |
| April 26, 2019 | 82705 | Class I | Terminated | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable T | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | accessdata.fda.gov |
| February 8, 2019 | 82212 | Class II | Terminated | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | accessdata.fda.gov |
| September 12, 2017 | 79167 | Class II | Terminated | Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasc | The tucking depth feature of this catheter introducer is marginally outside the upper specification. | accessdata.fda.gov |
| March 16, 2016 | 73833 | Class II | Terminated | PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath | Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve. | accessdata.fda.gov |
| November 6, 2015 | 76939 | Class II | Terminated | Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature. | Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature. | accessdata.fda.gov |
| August 5, 2015 | 76948 | Class II | Terminated | SurFlo IV Catheter | According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal. | accessdata.fda.gov |
| May 30, 2013 | 65397 | Class II | Terminated | Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature. | Medical devices were incorrectly labeled with extended expiration dates. | accessdata.fda.gov |
| June 3, 2011 | 59051 | Not yet classified | Terminated | Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty | Baloon catheter guidewires may become uncoiled during angioplasty procedures. | accessdata.fda.gov |
| June 24, 2010 | 58677 | Not yet classified | Terminated | Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic d | Molding defect in destination product that render the device unusable. | accessdata.fda.gov |
| June 8, 2010 | 58863 | Not yet classified | Terminated | Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Product Usage: Aspir | Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- All makers of Introducer, Catheter
- All makers of Wire, Guide, Catheter
- All makers of Catheter, Percutaneous
- All makers of Clamp, Vascular
- All makers of Device, Hemostasis, Vascular
Updated August 10, 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.