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Abiomed, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest FDA decision2026-06-15
TypeNumberDevice NameCodeDateActions
PMA P140003 Temporary non-roller type left heart support blood pumpOZD2026-06-15 View
PMA P170011 Temporary non-roller type right heart support blood pumpPYX2026-04-01 View
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

Related Clinical Trials

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