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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 K181122
Device Name CARDIOSAVE Intra-Aortic Balloon Pump
Datascope Corp.
1300 MacArthur Blvd.
Mahwah,  NJ  07430
Applicant Contact Hemang Kotecha
Datascope Corp.
1300 MacArthur Blvd.
Mahwah,  NJ  07430
Correspondent Contact Hemang Kotecha
Regulation Number870.3535
Classification Product Code
Date Received04/30/2018
Decision Date 05/31/2018
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