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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 K122628
Model 0684-00-0568-01
Device Name SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
Original Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield,  NJ  07004 0011
Original Contact carla s cerqueira
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/28/2012
Decision Date 09/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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