Advanced Cardiovascular Systems, Inc.

FDA 510(k) & PMA Approved Devices — 103 products

Total Devices103

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K012534	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	DQX	2002-01-24	View
510(k)	K000550	OTW MEGALINK SDS BILIARY STENT SYSTEM	FGE	2000-03-17	View
510(k)	K994229	VERIPATH PERIPHERAL GUIDING CATHETER	DQY	2000-02-25	View
510(k)	K992169	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	DQX	1999-10-28	View
510(k)	K990867	RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18	FGE	1999-09-02	View
510(k)	K963702	ACS HI-TORQUE IRON MAN GUIDE WIRE	DQX	1997-01-22	View
510(k)	K962495	INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)	MAV	1996-09-12	View
510(k)	K961471	INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)	MAV	1996-05-08	View
510(k)	K955175	ACS ANCHOR EXCHANGE DEVICE	DQX	1996-04-05	View
510(k)	K953987	ACS TOURGIDE GUIDING CATHETER	DQY	1995-12-07	View
510(k)	K952205	ACS POWERBASE GUILDING CATHETER	DQY	1995-08-04	View
510(k)	K950752	ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS	DQX	1995-05-15	View
510(k)	K950156	ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE	DQX	1995-04-05	View
510(k)	K946029	ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT	DQX	1995-02-24	View
510(k)	K942066	ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE	DQX	1994-07-18	View
510(k)	K940559	ACS POWERBASE(TM) CORONARY GUIDING CATHETER	DQY	1994-05-03	View
510(k)	K934624	ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE	DYB	1994-04-13	View
510(k)	K934009	ACS POWERGUIDE CORONARY GUIDING CATHETER	DQY	1994-01-11	View
510(k)	K934602	ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE	DQX	1993-12-16	View
510(k)	K934339	LOC GUIDE WIRE EXTENSION	DQX	1993-12-09	View