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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 K151254
Device Name CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
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 Received05/12/2015
Decision Date 07/02/2015
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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