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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 K063525
Device Name DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
Applicant
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -0011
Applicant Contact NANCY COHEN
Correspondent
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -0011
Correspondent Contact NANCY COHEN
Regulation Number870.3535
Classification Product Code
DSP  
Date Received11/22/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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