Abiomed, Inc. - FDA 510(k) Cleared Devices
19
Total
17
Cleared
0
Denied
FDA 510(k) cleared devices by Abiomed, Inc. Cardiovascular ✕
16 devices
Cleared
Oct 08, 2025
14Fr Low Profile Introducer Kit
Cardiovascular
40d
Cleared
Aug 06, 2024
Abiomed 14Fr Low Profile Introducer Kit
Cardiovascular
54d
Cleared
Jun 30, 2023
preCARDIA Occlusion System
Cardiovascular
422d
Cleared
Feb 23, 2023
OXY-1 System
Cardiovascular
139d
Cleared
Oct 13, 2022
Abiomed 14Fr Low Profile Introducer Set
Cardiovascular
87d
Cleared
Dec 07, 2020
Impella XR Sheath Set
Cardiovascular
112d
Cleared
Oct 23, 2020
OXY-1 System
Cardiovascular
280d
Cleared
Jun 15, 2020
Abiomed 23 Fr Sheath
Cardiovascular
49d
Cleared
Nov 18, 2019
Impella CP Introducer
Cardiovascular
49d
Cleared
Sep 06, 2012
IMPELLA 2.5 PLUS CATHETER
Cardiovascular
342d
Cleared
Apr 27, 2011
IMPELLA CONTROLLER WITH FLOW CONTROL
Cardiovascular
30d
Cleared
Jul 08, 2010
IMPELLA CONTROLLER
Cardiovascular
210d
Cleared
Apr 16, 2009
IMPELLA 5.0 CATHETER FAMILY
Cardiovascular
177d
Cleared
May 30, 2008
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
Cardiovascular
532d
Cleared
Dec 13, 2007
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
Cardiovascular
323d
Cleared
Dec 14, 2006
SUPRACOR BALLOON CATHETER
Cardiovascular
105d