Guidant Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
71
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061865FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05July 27, 2006
K061453HI-TORQUE WHISPER VIEW GUIDE WIREJune 22, 2006
K042908RX ACCUNET 2 EMBOLIC PROTECTION SYSTEMNovember 12, 2004
K042218ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEMAugust 31, 2004
K033834OMNILINK .018 BILIARY STENT SYSTEMJanuary 2, 2004
K033393ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEMNovember 10, 2003
K031678HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGAugust 26, 2003
K031459RAPIDO CUT-AWAY CUTTERJuly 23, 2003
K031398IS-1 HEMOSTASIS VALVE, MODEL 6799May 20, 2003
K030512GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEMMay 14, 2003
K030019MODIFICATION TO HI-TORQUE WHISPER GUIDEWIREJanuary 24, 2003
K023320AGILTRAC .035 PERIPHERAL DILATATION CATHETERDecember 10, 2002
K023627ESSEX ENDOSCOPE, MODEL SXD-1000November 12, 2002
K023300HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQOctober 28, 2002
K022738AGILTRAC .035 PERIPHERAL DILATATION CATHETERSeptember 13, 2002
K022880GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500September 13, 2002
K021455RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, August 2, 2002
K021824DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-3July 2, 2002
K021228HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIMay 15, 2002
K021285HI-TORQUE EXTRA S'PORT GUIDEWIREMay 2, 2002