FDA 510(k) Applications Submitted by Abiomed Inc.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K202330 | 08/17/2020 | Impella XR Sheath Set | Abiomed Inc. |
| K221294 | 05/04/2022 | preCARDIA Occlusion System | Abiomed Inc. |
| K222113 | 07/18/2022 | Abiomed 14Fr Low Profile Introducer Set | Abiomed Inc. |
| K223161 | 10/07/2022 | OXY-1 System | Abiomed Inc. |
| K201116 | 04/27/2020 | Abiomed 23 Fr Sheath | Abiomed Inc. |
| K200109 | 01/17/2020 | OXY-1 System | Abiomed Inc. |
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