Guidant Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K060449HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIREMay 30, 2006
K053459OMNILINK .035 BILIARY STENT SYSTEMApril 12, 2006
K053454RX HERCULINK ELITE BILIARY STENT SYSTEMMarch 6, 2006
K053019ACUITY STEERABLE STYLET ACCESSORYMarch 3, 2006
K052965EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.February 13, 2006
K052274GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000September 21, 2005
K052166MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEMAugust 18, 2005
K052165RX ACCUNET EMBOLIC PROTECTION SYSTEMAugust 16, 2005
K041981GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-20August 20, 2004
K041762FINISHING WIRE SUPPORTRAKAugust 6, 2004
K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020July 12, 2004
K031903RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568March 3, 2004
K032530MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEMOctober 23, 2003
K031688RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVEJuly 2, 2003
K031505RAPIDO CUT-AWAY GUIDING CATHETERJune 25, 2003