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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K965236
Device Name SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
Applicant
DATASCOPE CORP.
580 WINTERS AVE.
PARAMUS,  NJ  07652
Applicant Contact WILLIAM GOELLER
Correspondent
DATASCOPE CORP.
580 WINTERS AVE.
PARAMUS,  NJ  07652
Correspondent Contact WILLIAM GOELLER
Regulation Number870.3535
Classification Product Code
DSP  
Date Received12/31/1996
Decision Date 07/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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