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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