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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
Recalls CDRH Recalls
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