Clearance Summary
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit received FDA 510(k) clearance under submission number K261089, sponsored by Maduro Medical, 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 2026-09-14.
- Submission: K261089
- Applicant / Sponsor: Maduro Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2026-09-14
Classification & Regulation
This clearance is catalogued under FDA product code NRY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.