Numed Inc
Hopkinton, NY, US
NUMED, INC. appears in FDA device records in Hopkinton, NY. FDA records list 46 510(k) clearances between and , 8 PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 46 510(k) clearances for Numed Inc between 1985 and 2022. The busiest year on record is 2000, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1993 | 1 |
| 1996 | 1 |
| 2000 | 4 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2008 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 1 |
| 2016 | 3 |
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213915 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | |
| K211910 | Z-6 Atrioseptostomy Catheter | DXF | Substantially Equivalent | |
| K211134 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | |
| K190974 | D'Vill Introducer | DYB | Substantially Equivalent | |
| K171206 | D'Vill Introducer | DYB | Substantially Equivalent | |
| K161451 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | |
| K160598 | REBOA Balloon Catheter | MJN | Substantially Equivalent | |
| K160889 | BIB Stent Placement Catheter | NVM | Substantially Equivalent | |
| K131869 | PTS-X SIZING BALLOON CATHETER | MJN | Substantially Equivalent | |
| K122012 | Z-MED Z-MED II | OZT | Substantially Equivalent | |
| K121859 | TYSHAK NUCLEUS | DQY | Substantially Equivalent | |
| DEN080015 | NUCLEUS-X PTV CATHETER | OZT | Unknown | |
| K110903 | PTS-X SIZING BALLOON CATHETER | MJN | Substantially Equivalent | |
| K102473 | MULLINS-X PTV CATHETER | OMZ | Substantially Equivalent | |
| K082868 | MULLINS-X, MODEL 250X | DQY | Substantially Equivalent | |
| K082524 | MINI GHOST, MODEL: 507 | DQY | Substantially Equivalent | |
| K081680 | NUCLEUS-X, MODEL 230X | DQY | Substantially Equivalent | |
| K051343 | MINI GHOST PTA CATHETER, MODEL 507 | DQY | Substantially Equivalent | |
| K050857 | BIB PTA BALLOON CATHETER | NVM | Unknown | |
| K040830 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | DQO | Substantially Equivalent | |
| K041306 | NUMED PTS X SIZING BALLOON CATHETER | MJN | Substantially Equivalent | |
| K041093 | NUMED MULLINS X PTA CATHETER | DQY | Substantially Equivalent | |
| K032591 | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER | DQY | Substantially Equivalent | |
| K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS | DQY | Substantially Equivalent | |
| K022722 | PTA AND PTV | DQY | Substantially Equivalent | |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | OMZ | Substantially Equivalent | |
| K013601 | NUMED MULLINS PTA CATHETER | DQY | Substantially Equivalent | |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | DXF | Substantially Equivalent | |
| K003320 | PTA-OS SIZING BALLOON, MODEL 360 | MJN | Substantially Equivalent | |
| K010880 | NUMED HIGH PRESSURE PTA CATHETERS | DQY | Substantially Equivalent | |
| K003972 | NUMED GHOST II PTA CATHETERS | LIT | Substantially Equivalent | |
| K003643 | NUMED Z-MED PTV CATHERERS | DQY | Substantially Equivalent | |
| K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 | LIT | Substantially Equivalent | |
| K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 | LIT | Substantially Equivalent | |
| K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | DXF | Substantially Equivalent | |
| K960070 | NUMED ATRIOSEPTOSTOMY CATHETER | DQO | Substantially Equivalent | |
| K931009 | TYSHAK PERIPHERAL BALLOON DILATION CATHETER | LIT | Substantially Equivalent | |
| K883948 | MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER | DYG | Substantially Equivalent | |
| K881893 | NUMED BALLOON THERMODILUTION CATHETER | KRB | Substantially Equivalent | |
| K871796 | NUMED PTA CATHETERS | LIT | Substantially Equivalent | |
| K864943 | NUMED BALLOON WEDGE PRESSURE CATHETER | DQO | Substantially Equivalent | |
| K864940 | NUMED BALLOON ANGIOGRAPHIC CATHETERS | DQO | Substantially Equivalent | |
| K860121 | INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER | DPT | Substantially Equivalent | |
| K851845 | NUMED TEMP. STYLET PACING PAROBE 1318694 | LDF | Substantially Equivalent | |
| K851246 | NUMED BALLOON PACING CATHETER | LDF | Substantially Equivalent | |
| K843290 | NUMED BALLOON PACING CATHETER | LDF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1318694 | 1318694 | NUMED, INC. | 2880 MAIN ST., Hopkinton, NY 12965 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PNFAortic Stent
- OZTBalloon Aortic Valvuloplasty
- LITCatheter, Angioplasty, Peripheral, Transluminal
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
- DYGCatheter, Flow Directed
- MJNCatheter, Intravascular Occluding, Temporary
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- MADCatheter, Percutaneous (Valvuloplasty)
- DXFCatheter, Septostomy
- LDFElectrode, Pacemaker, Temporary
- DYBIntroducer, Catheter
- DPTProbe, Blood-Flow, Extravascular
- KRBProbe, Thermodilution
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- NPVPulmonary Valve Prosthesis Percutaneously Delivered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1754-2025 | 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. | Class II | Terminated | |
| Z-0511-2019 | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel. | Instructions for Use booklets were not included on the outer pouch | Class II | Terminated | |
| Z-0510-2019 | 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 medium and pressure measurement in any chamber or vessel. | Instructions for Use booklets were not included on the outer pouch | Class II | Terminated | |
| Z-0509-2010 | 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., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device. | 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, the packaging must remain intact. | Terminated | ||
| Z-0983-03 | 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 stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths. | Lacks a PMA or 510k. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain