510(k) K254035
K254035 is an FDA 510(k) premarket notification submitted by MicroVention, Inc., d/b/a Terumo Neuro for the device "Mayumi Thrombectomy System". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. MicroVention, Inc., d/b/a Terumo Neuro has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2026
- Date Received
- December 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aspiration Thrombectomy Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.