Datascope Corp. - FDA 510(k) Cleared Devices
136
Total
135
Cleared
0
Denied
120 devices
Cleared
Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS...
Cardiovascular
95d
Cleared
Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
Cardiovascular
87d
Cleared
May 13, 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
Cardiovascular
212d
Cleared
Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
Cardiovascular
232d
Cleared
May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH...
Cardiovascular
88d
Cleared
May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR...
Cardiovascular
88d
Cleared
Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
Cardiovascular
85d
Cleared
Jul 01, 1997
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
Cardiovascular
182d
Cleared
Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR...
Cardiovascular
94d
Cleared
Nov 15, 1996
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
Cardiovascular
210d
Cleared
Apr 24, 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
Cardiovascular
99d
Cleared
Dec 22, 1995
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
Cardiovascular
499d
Cleared
Feb 24, 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
Cardiovascular
277d
Cleared
Dec 09, 1994
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
Cardiovascular
88d
Cleared
Sep 13, 1994
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
Cardiovascular
238d
Cleared
Aug 09, 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC...
Cardiovascular
209d
Cleared
Aug 25, 1993
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
Cardiovascular
901d
Cleared
Aug 25, 1993
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
Cardiovascular
671d
Cleared
Aug 06, 1993
DATASCOPE 6000 MONITOR
Cardiovascular
246d
Cleared
Aug 03, 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
Cardiovascular
547d
Cleared
Aug 02, 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
Cardiovascular
958d
Cleared
Apr 27, 1993
SYSTEM 97
Cardiovascular
349d
Cleared
Feb 10, 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
Cardiovascular
310d
Cleared
Mar 11, 1992
DATASCOPE SYSTEM 95
Cardiovascular
268d
Cleared
Mar 11, 1992
SYSTEM 90 AND SYSTEM 90T
Cardiovascular
197d
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