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. Cardiovascular ✕
50 devices
Cleared
Jun 22, 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
Cardiovascular
28d
Cleared
Nov 12, 2004
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
Cardiovascular
22d
Cleared
Aug 31, 2004
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
Cardiovascular
26d
Cleared
Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Cardiovascular
88d
Cleared
Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
Cardiovascular
76d
Cleared
May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
Cardiovascular
15d
Cleared
Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
Cardiovascular
21d
Cleared
Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
Cardiovascular
67d
Cleared
Oct 28, 2002
HI-TORQUE WHISPER LS
Cardiovascular
25d
Cleared
Sep 13, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
Cardiovascular
25d
Cleared
Sep 13, 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
Cardiovascular
14d
Cleared
Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
Cardiovascular
88d
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