510(k) K253730
K253730 is an FDA 510(k) premarket notification submitted by Verge Medical, Inc. for the device "RoVo Mechanical Thrombectomy System". The FDA issued a decision of Substantially Equivalent on January 21, 2026. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Verge Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2026
- Date Received
- November 24, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peripheral Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.