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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
Original Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield,  NJ  07004 -0011
Original 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
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