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Abiomed, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252766 14Fr Low Profile Introducer KitDYB2025-10-08 View
510(k) K241708 Abiomed 14Fr Low Profile Introducer KitDYB2024-08-06 View
510(k) K221294 preCARDIA Occlusion SystemMJN2023-06-30 View
510(k) K223161 OXY-1 SystemDTZ2023-02-23 View
510(k) K222113 Abiomed 14Fr Low Profile Introducer SetDYB2022-10-13 View
510(k) K202330 Impella XR Sheath SetDYB2020-12-07 View
510(k) K200109 OXY-1 SystemDTZ2020-10-23 View
510(k) K201116 Abiomed 23 Fr SheathDYB2020-06-15 View
510(k) K192769 Impella CP IntroducerDYB2019-11-18 View
510(k) K112892 IMPELLA 2.5 PLUS CATHETERPBL2012-09-06 View
510(k) K110845 IMPELLA CONTROLLER WITH FLOW CONTROLKFM2011-04-27 View
510(k) K093801 IMPELLA CONTROLLERKFM2010-07-08 View
510(k) K083111 IMPELLA 5.0 CATHETER FAMILYKFM2009-04-16 View
510(k) K063723 IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEMKFM2008-05-30 View
510(k) K070225 SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLEDSP2007-12-13 View
510(k) K062582 SUPRACOR BALLOON CATHETERDSP2006-12-14 View
510(k) K911643 ABIODENT PERIOTEMP(R) SYSTEMEIL1991-07-09 View
510(k) K900574 ABIOMED BODY LEAD ANALYZER MODEL 200/20JAO1990-03-15 View
510(k) K885075 ABIOMED PERIOTEMP(TM) PROBEEIL1989-02-13 View
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