Medical Device Manufacturer · US , Hopkinton , NY

NuMED, Inc.

49 submissions · 47 cleared · Since 1985
49
Total
47
Cleared
1
Denied

NuMED, Inc. — FDA 510(k) Submissions

NuMED, Inc. has submitted 49 FDA 510(k) premarket notifications since 1985, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Catheter, Angioplasty, Peripheral, Transluminal, Catheter, Intravascular Occluding, Temporary, Catheter, Intravascular, Diagnostic, Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon . Use the specialty filter in the sidebar to narrow results.

49 devices
1–25 of 49
BIB Stent Placement Catheter
K213915 · NVM Catheter, Angioplasty,... · Cardiovascular
Jan 2022 28d
Z-6 Atrioseptostomy Catheter
K211910 · DXF Catheter, Septostomy · Cardiovascular
Jul 2021 28d
BIB Stent Placement Catheter
K211134 · NVM Catheter, Angioplasty,... · Cardiovascular
May 2021 41d
D'Vill Introducer
K190974 · DYB Introducer, Catheter · Cardiovascular
May 2019 29d
D'Vill Introducer
K171206 · DYB Introducer, Catheter · Cardiovascular
Oct 2017 178d
BIB Stent Placement Catheter
K161451 · NVM Catheter, Angioplasty,... · Cardiovascular
Sep 2016 119d
REBOA Balloon Catheter
K160598 · MJN Catheter, Intravascular... · Cardiovascular
Jun 2016 110d
BIB Stent Placement Catheter
K160889 · NVM Catheter, Angioplasty,... · Cardiovascular
May 2016 50d
PTS-X SIZING BALLOON CATHETER
K131869 · MJN Catheter, Intravascular... · Cardiovascular
Aug 2013 45d
Z-MED Z-MED II
K122012 · OZT Balloon Aortic Valvuloplasty · Cardiovascular
Oct 2012 86d
TYSHAK NUCLEUS
K121859 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2012 66d
NUCLEUS-X PTV CATHETER
DEN080015 · OZT Balloon Aortic Valvuloplasty · Cardiovascular
Jun 2012 1265d
PTS-X SIZING BALLOON CATHETER
K110903 · MJN Catheter, Intravascular... · Cardiovascular
Apr 2011 29d
MULLINS-X PTV CATHETER
K102473 · OMZ Pulmonary (pulmonic)... · Cardiovascular
Dec 2010 101d
MULLINS-X, MODEL 250X
K082868 · DQY Catheter, Percutaneous · Cardiovascular
Oct 2008 25d
MINI GHOST, MODEL: 507
K082524 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2008 24d
NUCLEUS-X, MODEL 230X
K081680 · DQY Catheter, Percutaneous · Cardiovascular
Jul 2008 23d
BIB PTA BALLOON CATHETER
K050857 · NVM Catheter, Angioplasty,... · Cardiovascular
Jul 2005 114d
MINI GHOST PTA CATHETER, MODEL 507
K051343 · DQY Catheter, Percutaneous · Cardiovascular
Jul 2005 66d
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · DQO Catheter, Intravascular,... · Cardiovascular
Jun 2004 79d
NUMED PTS X SIZING BALLOON CATHETER
K041306 · MJN Catheter, Intravascular... · Cardiovascular
Jun 2004 24d
NUMED MULLINS X PTA CATHETER
K041093 · DQY Catheter, Percutaneous · Cardiovascular
May 2004 9d
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2003 34d
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · DQY Catheter, Percutaneous · Cardiovascular
May 2003 85d
PTA AND PTV
K022722 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2002 28d
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