Medical Device Manufacturer · US , Mchenry , IL

Datascope Corp. - FDA 510(k) Cleared Devices

136 submissions · 135 cleared · Since 1976
136
Total
135
Cleared
0
Denied
120 devices
26-50 of 120
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS...
K994157 · DSP
Cardiovascular · 95d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · DSI
Cardiovascular · 87d
Cleared May 13, 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · DXN
Cardiovascular · 212d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · DRT
Cardiovascular · 232d
Cleared May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH...
K980780 · DSP
Cardiovascular · 88d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR...
K980385 · DSP
Cardiovascular · 88d
Cleared Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · DYB
Cardiovascular · 85d
Cleared Jul 01, 1997
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236 · DSP
Cardiovascular · 182d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR...
K964987 · DSP
Cardiovascular · 94d
Cleared Nov 15, 1996
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509 · DSP
Cardiovascular · 210d
Cleared Apr 24, 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166 · DSP
Cardiovascular · 99d
Cleared Dec 22, 1995
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
K943896 · DQX
Cardiovascular · 499d
Cleared Feb 24, 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454 · DSP
Cardiovascular · 277d
Cleared Dec 09, 1994
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
K944460 · DSP
Cardiovascular · 88d
Cleared Sep 13, 1994
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
K940231 · DSP
Cardiovascular · 238d
Cleared Aug 09, 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC...
K940178 · DSP
Cardiovascular · 209d
Cleared Aug 25, 1993
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
K911000 · DSP
Cardiovascular · 901d
Cleared Aug 25, 1993
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802 · DSP
Cardiovascular · 671d
Cleared Aug 06, 1993
DATASCOPE 6000 MONITOR
K926099 · MLC
Cardiovascular · 246d
Cleared Aug 03, 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · DSP
Cardiovascular · 547d
Cleared Aug 02, 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · DSP
Cardiovascular · 958d
Cleared Apr 27, 1993
SYSTEM 97
K922235 · DSP
Cardiovascular · 349d
Cleared Feb 10, 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · DSP
Cardiovascular · 310d
Cleared Mar 11, 1992
DATASCOPE SYSTEM 95
K912629 · DSP
Cardiovascular · 268d
Cleared Mar 11, 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · DSP
Cardiovascular · 197d

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