Clearance Summary
Liberant RX Aspiration Catheter received FDA 510(k) clearance under submission number K253589, sponsored by Medtronic Interventional Vascular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-04-23.
- Submission: K253589
- Applicant / Sponsor: Medtronic Interventional Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2026-04-23
Classification & Regulation
This clearance is catalogued under FDA product code QEZ and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.