NuMED, Inc.
Medical device manufacturer in Hopkinton, NY.
48510(k) clearances
1PMA approvals
4recalls
Device types
- DQY Catheter, Percutaneous 12
- LIT Catheter, Angioplasty, Peripheral… 7
- DQO Catheter, Intravascular, Diagnostic 5
- MJN Catheter, Intravascular Occluding, Temporary 5
- NVM Catheter, Angioplasty, Peripheral… 5
- LDF Electrode, Pacemaker, Temporary 3
- DXF Catheter, Septostomy 3
- OMZ Pulmonary (Pulmonic) Valvuloplasty… 2
- DYB Introducer, Catheter 2
- DPT Probe, Blood-Flow, Extravascular 1
- KRB Probe, Thermodilution 1
- DYG Catheter, Flow Directed 1
- OZT Balloon Aortic Valvuloplasty 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
| K211910 | Z-6 Atrioseptostomy CatheterDXF · Special | 07/19/2021SE |
| K211134 | BIB Stent Placement CatheterNVM · Special | 05/27/2021SE |
| K190974 | D'Vill IntroducerDYB · Special | 05/14/2019SE |
| K171206 | D'Vill IntroducerDYB · Traditional | 10/20/2017SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | 09/22/2016SE |
| K160598 | REBOA Balloon CatheterMJN · Traditional | 06/20/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | 05/20/2016SE |
| K131869 | Pts-X Sizing Balloon CatheterMJN · Special | 08/08/2013SE |
| K122012 | Z-Med Z-Med IIOZT · Traditional | 10/04/2012SE |
| K121859 | Tyshak NucleusDQY · Special | 08/31/2012SE |
| K110903 | Pts-X Sizing Balloon CatheterMJN · Special | 04/29/2011SE |
| K102473 | Mullins-X PTV CatheterOMZ · Traditional | 12/09/2010SE |
| K082868 | Mullins-X, Model 250XDQY · Special | 10/24/2008SE |
| K082524 | Mini Ghost, Model: 507DQY · Special | 09/26/2008SE |
| K081680 | Nucleus-X, Model 230XDQY · Special | 07/10/2008SE |
| K051343 | Mini Ghost Pta Catheter, Model 507DQY · Special | 07/28/2005SE |
| K050857 | Bib Pta Balloon CatheterNVM · Traditional | 07/28/2005SESU |
| K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersDQO · Special | 06/18/2004SE |
| K041306 | Numed PTS X Sizing Balloon CatheterMJN · Special | 06/10/2004SE |
| K041093 | Numed Mullins X Pta CatheterDQY · Special | 05/06/2004SE |
| K032591 | Numed Tyshak Mini Pediatric PTV CatheterDQY · Special | 09/25/2003SE |
| K030589 | Modification to Numed Tyshak II and Z-Med II PTV CathetersDQY · Special | 05/21/2003SE |
| K022722 | Pta and PTVDQY · Special | 09/13/2002SE |
| K014124 | Numed Coefficient PTV CathetersOMZ · Special | 01/16/2002SE |
| K013601 | Numed Mullins Pta CatheterDQY · Special | 01/03/2002SE |
| K011557 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersDXF · Special | 07/12/2001SE |
| K003320 | Pta-Os Sizing Balloon, Model 360MJN · Traditional | 05/02/2001SE |
| K010880 | Numed High Pressure Pta CathetersDQY · Special | 04/20/2001SE |
| K003972 | Numed Ghost II Pta CathetersLIT · Special | 01/11/2001SE |
| K003902 | Multitrack Angiographic CatheterDQO · Special | 01/11/2001SE |
| K003643 | Numed Z-Med PTV CatherersDQY · Special | 12/27/2000SE |
| K003276 | Tyshak Mini Pediatric PTV Catheter, Model 107LIT · Traditional | 12/01/2000SE |
| K003114 | Numed Tyshak and Z-Med PTV CathetersLIT · Special | 11/01/2000SE |
| K003052 | Numed Tyshak II and Z-Med II PTV CathetersLIT · Special | 11/01/2000SE |
| K991977 | Tyshak, Model 102 and Z-Med, Model 302LIT · Traditional | 09/27/2000SE |
| K001804 | Numed Z-5 Atrioseptostomy CatheterDXF · Special | 07/12/2000SE |
| K960070 | Numed Atrioseptostomy CatheterDQO · Traditional | 04/02/1996SE |
| K931009 | Tyshak Peripheral Balloon Dilation CatheterLIT · Traditional | 12/21/1993SE |
| K883948 | Modified Numed Balloon Angiographic CatheterDYG · Traditional | 04/21/1989SE |
| K881893 | Numed Balloon Thermodilution CatheterKRB · Traditional | 09/06/1988SE |
| K871796 | Numed Pta CathetersLIT · Traditional | 12/03/1987SE |
| K864943 | Numed Balloon Wedge Pressure CatheterDQO · Traditional | 02/20/1987SE |
| K864940 | Numed Balloon Angiographic CathetersDQO · Traditional | 02/19/1987SE |
| K860121 | Intravascular Catheter W/Doppler TransducerDPT · Traditional | 06/02/1986SE |
| K851845 | Numed Temp. Stylet Pacing Parobe 1318694LDF · Traditional | 08/29/1985SE |
| K851246 | Numed Balloon Pacing CatheterLDF · Traditional | 04/19/1985SE |
| K843290 | Numed Balloon Pacing CatheterLDF · Traditional | 01/14/1985SE |
PMA approvals
- P150028 CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) · 03/25/2016 · 7 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1754-2025 Class II | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was… | 04/21/2025Terminated |
| Z-0511-2019 Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage:…Instructions for Use booklets were not included on the outer pouch | 10/17/2018Terminated |
| Z-0510-2019 Class II | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage:…Instructions for Use booklets were not included on the outer pouch | 10/17/2018Terminated |
| Z-0509-2010 | IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number…The firm received a complaint from the sole direct account that while performing an inventory review it was… | 09/23/2009Terminated |