FDA 510(k) Application Details - K112892

Device Classification Name	More FDA Info for this Device
510(K) Number	K112892
Device Name	IMPELLA 2.5 PLUS CATHETER
Applicant	ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	CAROLYN PEKAR Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2011
Decision Date	09/06/2012
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review