Peripheral Systems Group - FDA 510(k) Cleared Devices
17
Total
17
Cleared
0
Denied
12 devices
Cleared
Dec 09, 1993
VANTAGE DIALTAION CATHETER
Cardiovascular
87d
Cleared
Jul 14, 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
Cardiovascular
120d
Cleared
Feb 09, 1993
HI-TORQUE SPORT-T(TM) GUIDE WIRE
Cardiovascular
426d
Cleared
Sep 16, 1992
EDM(R) INFUSION CATHETER
Cardiovascular
315d
Cleared
Feb 19, 1992
PROFLEX 5
Cardiovascular
96d
Cleared
Apr 12, 1991
ADVANCE 418(TM)
Cardiovascular
161d
Cleared
Dec 17, 1990
PSG HEMOSTATIC CONTROL VALVE
Cardiovascular
42d
Cleared
Nov 07, 1990
DOPPLER NEEDLE AND FLOW MONITOR
Cardiovascular
89d
Cleared
Feb 28, 1990
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
Cardiovascular
202d
Cleared
Jan 19, 1990
BALLOON DILATATION CATHETER
Cardiovascular
169d
Cleared
Jan 19, 1990
GUIDING CATHETER
Cardiovascular
150d
Cleared
Jan 04, 1990
PSG(TM) EDM(TM) INFUSION CATHETER
Cardiovascular
86d