Ev3, Inc. - FDA 510(k) Cleared Devices
Recent clearances: NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER, NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER, RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
35
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ev3, Inc. Gastroenterology & Urology ✕
10 devices
Cleared
Mar 18, 2008
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
Gastroenterology & Urology
214d
Cleared
Aug 31, 2006
PRIMUS GPS BILIARY STENT SYSTEM
Gastroenterology & Urology
86d
Cleared
Mar 08, 2006
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
Gastroenterology & Urology
58d
Cleared
Dec 09, 2004
PRIMUS STENT AND DELIVERY SYSTEM
Gastroenterology & Urology
16d
Cleared
Aug 23, 2004
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
Gastroenterology & Urology
7d
Cleared
Apr 28, 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
Gastroenterology & Urology
47d
Cleared
Nov 21, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
Gastroenterology & Urology
37d
Cleared
Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
Gastroenterology & Urology
48d
Cleared
Oct 22, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
Gastroenterology & Urology
62d
Cleared
Aug 08, 2003
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
Gastroenterology & Urology
21d