Clearance Summary
IMPELLA 2.5 PLUS CATHETER received FDA 510(k) clearance under submission number K112892, sponsored by Abiomed, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-09-06.
- Submission: K112892
- Applicant / Sponsor: Abiomed, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class:
- Decision date: 2012-09-06
Classification & Regulation
This clearance is catalogued under FDA product code PBL , within the Cardiovascular review panel as a device.