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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 K133074
Device Name MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Applicant Contact LINDA SLUTZKY
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Correspondent Contact LINDA SLUTZKY
Regulation Number870.3535
Classification Product Code
DSP  
Date Received09/30/2013
Decision Date 12/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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