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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 K031636
Device Name CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
Applicant
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Applicant Contact SUSAN MANDY
Correspondent
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Correspondent Contact SUSAN MANDY
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/27/2003
Decision Date 08/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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