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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 K163542
Device Name CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
Applicant
Datascope Corp.
1300 MacArthur Blvd.
Mahwah,  NJ  07430
Applicant Contact Helder A. Sousa
Correspondent
Datascope Corp.
1300 MacArthur Blvd.
Mahwah,  NJ  07430
Correspondent Contact Helder A. Sousa
Regulation Number870.3535
Classification Product Code
DSP  
Date Received12/16/2016
Decision Date 01/31/2017
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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