Advanced Cardiovascular Systems, Inc. - FDA 510(k) Cleared Devices
103
Total
100
Cleared
0
Denied
FDA 510(k) Regulatory Record - Advanced Cardiovascular Systems, Inc. Cardiovascular ✕
99 devices
Cleared
Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Cardiovascular
171d
Cleared
Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
Cardiovascular
71d
Cleared
Oct 28, 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
Cardiovascular
122d
Cleared
Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
Cardiovascular
128d
Cleared
Sep 12, 1996
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING...
Cardiovascular
78d
Cleared
May 08, 1996
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR...
Cardiovascular
21d
Cleared
Apr 05, 1996
ACS ANCHOR EXCHANGE DEVICE
Cardiovascular
144d
Cleared
Dec 07, 1995
ACS TOURGIDE GUIDING CATHETER
Cardiovascular
106d
Cleared
Aug 04, 1995
ACS POWERBASE GUILDING CATHETER
Cardiovascular
86d
Cleared
May 15, 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
Cardiovascular
87d
Cleared
Apr 05, 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
Cardiovascular
78d
Cleared
Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
Cardiovascular
77d
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