Data / Medical devices / United States / Numed, Inc.
Numed, Inc.: FDA-registered device maker in Hopkinton, NY, United States, 25 510(k) clearances and 1 PMA approval
Numed, Inc. is registered with the FDA (registration 1318694) in Hopkinton, NY, United States. It lists 12 device types. The FDA files 25 510(k) clearances and 1 PMA approval under its listings, the newest dated July 19, 2021. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1318694
- Address
- 2880 Main ST., Hopkinton, NY, United States, 12965
- Owner or operator
- NUMED, INC. (1318694)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- July 7, 1992
- Registered through
- 2027
- Brand names listed
- Atrioseptostomy, BIB, BIB CATHETER, BIB Stent Placement Catheter, Bonhoeffer Mitral Valve Kit, COEfficient, CP Stent, Covered CP Stent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Stent | PNF | 3 | Manufacturer | accessdata.fda.gov |
| Balloon Aortic Valvuloplasty | OZT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | NVM | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous (Valvuloplasty) | MAD | 3 | Manufacturer for export | accessdata.fda.gov |
| Catheter, Septostomy | DXF | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | 2 | Manufacturer | accessdata.fda.gov |
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | f | Contract manufacturer | 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 19, 2021 | K211910 | Z-6 Atrioseptostomy Catheter | DXF | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 27, 2021 | K211134 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| October 20, 2017 | K171206 | D'Vill Introducer | DYB | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| September 22, 2016 | K161451 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| June 20, 2016 | K160598 | REBOA Balloon Catheter | MJN | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 20, 2016 | K160889 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| October 4, 2012 | K122012 | Z-MED Z-MED II | OZT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| August 31, 2012 | K121859 | TYSHAK NUCLEUS | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| June 11, 2012 | DEN080015 | NUCLEUS-X PTV CATHETER | OZT | Unknown | NuMED, Inc. | accessdata.fda.gov |
| July 10, 2008 | K081680 | NUCLEUS-X, MODEL 230X | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| July 28, 2005 | K051343 | MINI GHOST PTA CATHETER, MODEL 507 | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| July 28, 2005 | K050857 | BIB PTA BALLOON CATHETER | NVM | Unknown | NuMED, Inc. | accessdata.fda.gov |
| June 10, 2004 | K041306 | NUMED PTS X SIZING BALLOON CATHETER | MJN | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 6, 2004 | K041093 | NUMED MULLINS X PTA CATHETER | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 21, 2003 | K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| September 13, 2002 | K022722 | PTA AND PTV | DQY | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| January 16, 2002 | K014124 | NUMED COEFFICIENT PTV CATHETERS | OMZ | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| May 2, 2001 | K003320 | PTA-OS SIZING BALLOON, MODEL 360 | MJN | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| December 1, 2000 | K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| November 1, 2000 | K003114 | NUMED TYSHAK AND Z-MED PTV CATHETERS | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| November 1, 2000 | K003052 | NUMED TYSHAK II AND Z-MED II PTV CATHETERS | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| September 27, 2000 | K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 | LIT | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| April 2, 1996 | K960070 | NUMED ATRIOSEPTOSTOMY CATHETER | DQO | Substantially Equivalent | NuMED, Inc. | accessdata.fda.gov |
| January 29, 1996 | K952984 | MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) | DQO | Substantially Equivalent | Map Medical Equipment, Inc. | accessdata.fda.gov |
| December 21, 1993 | K931009 | TYSHAK PERIPHERAL BALLOON DILATION CATHETER | LIT | Substantially Equivalent | NuMED, 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 |
|---|---|---|---|---|---|---|
| March 25, 2016 | P150028 | CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) | PNF | 7 | July 6, 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 |
|---|---|---|---|---|---|---|
| April 21, 2025 | 96734 | Class II | Terminated | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon. | accessdata.fda.gov |
| October 17, 2018 | 81460 | Class II | Terminated | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast | Instructions for Use booklets were not included on the outer pouch | accessdata.fda.gov |
| September 23, 2009 | 53495 | Not yet classified | Terminated | IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 8 | The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured | accessdata.fda.gov |
| June 26, 2003 | 26556 | Not yet classified | Terminated | CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the st | Lacks a PMA or 510k. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Septostomy
- All makers of Catheter, Percutaneous
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Balloon Aortic Valvuloplasty
- All makers of Catheter, Intravascular, Diagnostic
Updated July 6, 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.