Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Abiomed, Inc.

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

Total Devices11
Categories5
Latest Approval2025-10-08
TypeNumberDevice NameCodeDate
510(k) K252766 14Fr Low Profile Introducer Kit DYB 2025-10-08 View
510(k) K241708 Abiomed 14Fr Low Profile Introducer Kit DYB 2024-08-06 View
510(k) K221294 preCARDIA Occlusion System MJN 2023-06-30 View
510(k) K223161 OXY-1 System DTZ 2023-02-23 View
510(k) K222113 Abiomed 14Fr Low Profile Introducer Set DYB 2022-10-13 View
510(k) K202330 Impella XR Sheath Set DYB 2020-12-07 View
510(k) K200109 OXY-1 System DTZ 2020-10-23 View
510(k) K201116 Abiomed 23 Fr Sheath DYB 2020-06-15 View
510(k) K192769 Impella CP Introducer DYB 2019-11-18 View
PMA P170011 Temporary non-roller type right heart support blood pump PYX 2017-12-13 View
PMA P140003 Temporary non-roller type left heart support blood pump OZD 2016-12-07 View
↑