Ev3, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 18, 2008

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05

K072301 · FGE

Gastroenterology & Urology · 214d

Cleared Aug 31, 2006

PRIMUS GPS BILIARY STENT SYSTEM

K061566 · FGE

Gastroenterology & Urology · 86d

Cleared Mar 08, 2006

PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

K060057 · FGE

Gastroenterology & Urology · 58d

Cleared Dec 09, 2004

PRIMUS STENT AND DELIVERY SYSTEM

K043243 · FGE

Gastroenterology & Urology · 16d

Cleared Aug 23, 2004

MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT

K042204 · FGE

Gastroenterology & Urology · 7d

Cleared Apr 28, 2004

PARAMOUNT MINI GPS BILIARY STENT SYSTEM

K040653 · FGE

Gastroenterology & Urology · 47d

Cleared Nov 21, 2003

PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

K033314 · FGE

Gastroenterology & Urology · 37d

Cleared Nov 17, 2003

MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM

K033134 · FGE

Gastroenterology & Urology · 48d

Cleared Oct 22, 2003

PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

K032580 · FGE

Gastroenterology & Urology · 62d

Cleared Aug 08, 2003

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION

K032206 · FGE

Gastroenterology & Urology · 21d