Guidant Corp. - FDA 510(k) Cleared Devices
Recent clearances: FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05, HI-TORQUE WHISPER VIEW GUIDE WIRE, RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
71
Total
56
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guidant Corp. Gastroenterology & Urology ✕
17 devices
Cleared
Jan 02, 2004
OMNILINK .018 BILIARY STENT SYSTEM
Gastroenterology & Urology
23d
Cleared
Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
Gastroenterology & Urology
18d
Cleared
Jul 02, 2002
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS...
Gastroenterology & Urology
28d
Cleared
Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
Gastroenterology & Urology
29d
Cleared
Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
Gastroenterology & Urology
33d
Cleared
Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
Gastroenterology & Urology
30d
Cleared
Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
Gastroenterology & Urology
30d
Cleared
May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
Gastroenterology & Urology
33d
Cleared
Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
Gastroenterology & Urology
35d
Cleared
Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
Gastroenterology & Urology
87d
Cleared
May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18,...
Gastroenterology & Urology
30d
Cleared
May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13,...
Gastroenterology & Urology
30d