Datascope Corp. - FDA 510(k) Cleared Devices
136
Total
135
Cleared
0
Denied
120 devices
Cleared
Jun 20, 1989
INTRA AORTIC BALLOON
Cardiovascular
19d
Cleared
Jun 12, 1989
ROTATING HEMOSTATIC VALVE
Cardiovascular
116d
Cleared
Nov 04, 1988
CORONARY GUIDE WIRE
Cardiovascular
74d
Cleared
Aug 19, 1988
3000 PHYSIOLOGICAL MONITOR
Cardiovascular
207d
Cleared
Jun 10, 1988
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
Cardiovascular
137d
Cleared
Jun 01, 1988
ACCUCOM 2
Cardiovascular
232d
Cleared
Mar 25, 1987
GUIDE WIRE
Cardiovascular
34d
Cleared
Feb 10, 1987
DATASCOPE BALLOON DILATATION CATHETER
Cardiovascular
147d
Cleared
Jan 14, 1987
SYSTEM 90 TRANSPORT
Cardiovascular
147d
Cleared
Jan 02, 1987
2200I PHYSIOLOGICAL MONITOR
Cardiovascular
130d
Cleared
Nov 06, 1986
PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)
Cardiovascular
13d
Cleared
Jun 05, 1986
2500 PRINTER
Cardiovascular
139d
Cleared
Aug 22, 1985
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
Cardiovascular
196d
Cleared
Apr 01, 1985
PHYSIOLOGICAL MONITOR 2100
Cardiovascular
143d
Cleared
Mar 01, 1985
ACCUTORR CSM SYSTEM
Cardiovascular
246d
Cleared
Feb 08, 1985
IABP #90 SYSTEM
Cardiovascular
665d
Cleared
Feb 08, 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
Cardiovascular
464d
Cleared
Jan 14, 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
Cardiovascular
59d
Cleared
Nov 02, 1983
PECOR 8.5 FRENCH IAB ON A DATASCOPE
Cardiovascular
194d
Cleared
Nov 02, 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
Cardiovascular
187d
Cleared
Oct 19, 1983
PERCLUDER DL OCCLUDING BALLOON
Cardiovascular
92d
Cleared
Jan 24, 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
Cardiovascular
77d
Cleared
Dec 21, 1982
DATASCOPE MODEL 83 IABP SYSTEM
Cardiovascular
174d
Cleared
Oct 18, 1982
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
Cardiovascular
202d
Cleared
Aug 19, 1982
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
Cardiovascular
126d
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