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
51-75 of 120
Not Cleared Nov 05, 1991
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997 · DSP
Cardiovascular · 242d
Cleared Oct 15, 1991
DATASCOPE PASSPORT MONITOR
K911598 · DRT
Cardiovascular · 189d
Cleared Jun 25, 1991
TURBO SUPPORT CATHETER
K910116 · DQY
Cardiovascular · 166d
Cleared Jun 11, 1991
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
K905056 · DSP
Cardiovascular · 215d
Cleared Jan 30, 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K905432 · DQX
Cardiovascular · 57d
Cleared Jan 16, 1991
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · DQR
Cardiovascular · 212d
Cleared Dec 10, 1990
VESSEL DILATOR
K904476 · DRE
Cardiovascular · 70d
Cleared Dec 06, 1990
GUIDEWIRE
K904477 · DQX
Cardiovascular · 66d
Cleared Nov 16, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 50CC
K903930 · DSP
Cardiovascular · 84d
Cleared Oct 22, 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414 · DSP
Cardiovascular · 63d
Cleared Oct 19, 1990
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
K903769 · DSP
Cardiovascular · 60d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 40CC
K903867 · DSP
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
K903892 · DSP
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
K903893 · DSP
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
K904018 · DSP
Cardiovascular · 50d
Cleared Oct 16, 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · DYB
Cardiovascular · 105d
Cleared Oct 09, 1990
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
K903736 · DSP
Cardiovascular · 54d
Cleared Sep 25, 1990
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
K902057 · DSP
Cardiovascular · 141d
Cleared Aug 17, 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · DSP
Cardiovascular · 276d
Cleared Jun 26, 1990
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
K901391 · DYB
Cardiovascular · 92d
Cleared Jun 21, 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · DQX
Cardiovascular · 90d
Cleared Feb 05, 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430 · DSP
Cardiovascular · 89d
Cleared Nov 01, 1989
DATASCOPE STEERING HANDLE
K894940 · DQX
Cardiovascular · 90d
Cleared Oct 12, 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · DQX
Cardiovascular · 90d
Cleared Jun 20, 1989
GUIDE WIRE INTRODUCER
K890807 · DQX
Cardiovascular · 124d

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