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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name temporary cardiac support blood pump
510(k) Number K112892
Device Name IMPELLA 2.5 PLUS CATHETER
Original Applicant
ABIOMED, INC.
22 cherry hill dr.
danvers,  MA  01923
Original Contact carolyn pekar
Regulation Number870.4360
Classification Product Code
PBL  
Date Received09/30/2011
Decision Date 09/06/2012
Decision se - with limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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