Guidant Corp.

FDA 510(k) & PMA Approved Devices — 71 products

Total Devices71

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K061865	FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05	NEY	2006-07-27	View
510(k)	K061453	HI-TORQUE WHISPER VIEW GUIDE WIRE	DQX	2006-06-22	View
510(k)	K042908	RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM	NTE	2004-11-12	View
510(k)	K042218	ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM	NTE	2004-08-31	View
510(k)	K033834	OMNILINK .018 BILIARY STENT SYSTEM	FGE	2004-01-02	View
510(k)	K033393	ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM	FGE	2003-11-10	View
510(k)	K031678	HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	DQX	2003-08-26	View
510(k)	K031459	RAPIDO CUT-AWAY CUTTER	DQY	2003-07-23	View
510(k)	K031398	IS-1 HEMOSTASIS VALVE, MODEL 6799	DTL	2003-05-20	View
510(k)	K030512	GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM	GCJ	2003-05-14	View
510(k)	K030019	MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE	DQX	2003-01-24	View
510(k)	K023320	AGILTRAC .035 PERIPHERAL DILATATION CATHETER	DQY	2002-12-10	View
510(k)	K023627	ESSEX ENDOSCOPE, MODEL SXD-1000	GCJ	2002-11-12	View
510(k)	K023300	HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J	DQX	2002-10-28	View
510(k)	K022880	GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500	DXC	2002-09-13	View
510(k)	K022738	AGILTRAC .035 PERIPHERAL DILATATION CATHETER	DQY	2002-09-13	View
510(k)	K021455	RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,	DQY	2002-08-02	View
510(k)	K021824	DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010	FGE	2002-07-02	View
510(k)	K021228	HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE	DQX	2002-05-15	View
510(k)	K021282	LV-1 HEMOSTASIS VALVE, MODEL #6789	DTL	2002-05-02	View