Datascope Corp. - FDA 510(k) Cleared Devices
136
Total
135
Cleared
0
Denied
136 devices
Cleared
Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
Cardiovascular
29d
Cleared
Aug 25, 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
Cardiovascular
22d
Cleared
May 12, 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER...
Cardiovascular
29d
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
Mar 13, 1998
GAS MODULE II, MODEL 0998-00-0143
Anesthesiology
72d
Cleared
Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
Cardiovascular
85d
Cleared
Sep 25, 1997
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
Anesthesiology
261d
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 25, 1993
DATASCOPE MULTINEX II
Anesthesiology
244d
Cleared
Aug 06, 1993
DATASCOPE 6000 MONITOR
Cardiovascular
246d
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