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FDA 510(k) Applications Submitted by Abiomed, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K112892
09/30/2011
IMPELLA 2.5 PLUS CATHETER
ABIOMED, INC.
K110845
03/28/2011
IMPELLA CONTROLLER WITH FLOW CONTROL
ABIOMED, INC.
K192769
09/30/2019
Impella CP Introducer
Abiomed, Inc.
K093801
12/10/2009
IMPELLA CONTROLLER
ABIOMED, INC.
K070225
01/24/2007
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
ABIOMED, INC.
K063723
12/15/2006
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
ABIOMED, INC.
K062582
08/31/2006
SUPRACOR BALLOON CATHETER
ABIOMED, INC.
K083111
10/21/2008
IMPELLA 5.0 CATHETER FAMILY
ABIOMED, INC.
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