Clearance Summary
Mayumi Thrombectomy System received FDA 510(k) clearance under submission number K254035, sponsored by MicroVention, Inc., d/b/a Terumo Neuro. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-09-03.
- Submission: K254035
- Applicant / Sponsor: MicroVention, Inc., d/b/a Terumo Neuro
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2026-09-03
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.