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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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