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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 K120868
Device Name MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 LAW DR.
FAIRFIELD,  NJ  07004 -0011
Applicant Contact HELDER A SOUSA
Correspondent
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 LAW DR.
FAIRFIELD,  NJ  07004 -0011
Correspondent Contact HELDER A SOUSA
Regulation Number870.3535
Classification Product Code
DSP  
Date Received03/22/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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