Abiomed, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 08, 2025

14Fr Low Profile Introducer Kit

K252766 · DYB

Cardiovascular · 40d

Cleared Aug 06, 2024

Abiomed 14Fr Low Profile Introducer Kit

K241708 · DYB

Cardiovascular · 54d

Cleared Jun 30, 2023

preCARDIA Occlusion System

K221294 · MJN

Cardiovascular · 422d

Cleared Feb 23, 2023

OXY-1 System

K223161 · DTZ

Cardiovascular · 139d

Cleared Oct 13, 2022

Abiomed 14Fr Low Profile Introducer Set

K222113 · DYB

Cardiovascular · 87d

Cleared Dec 07, 2020

Impella XR Sheath Set

K202330 · DYB

Cardiovascular · 112d

Cleared Oct 23, 2020

OXY-1 System

K200109 · DTZ

Cardiovascular · 280d

Cleared Jun 15, 2020

Abiomed 23 Fr Sheath

K201116 · DYB

Cardiovascular · 49d

Cleared Nov 18, 2019

Impella CP Introducer

K192769 · DYB

Cardiovascular · 49d

Cleared Sep 06, 2012

IMPELLA 2.5 PLUS CATHETER

K112892 · PBL

Cardiovascular · 342d

Cleared Apr 27, 2011

IMPELLA CONTROLLER WITH FLOW CONTROL

K110845 · KFM

Cardiovascular · 30d

Cleared Jul 08, 2010

IMPELLA CONTROLLER

K093801 · KFM

Cardiovascular · 210d

Cleared CT Apr 16, 2009

IMPELLA 5.0 CATHETER FAMILY

K083111 · KFM

Cardiovascular · 177d

Cleared May 30, 2008

IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM

K063723 · KFM

Cardiovascular · 532d

Cleared Dec 13, 2007

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE

K070225 · DSP

Cardiovascular · 323d

Cleared Dec 14, 2006

SUPRACOR BALLOON CATHETER

K062582 · DSP

Cardiovascular · 105d