510(k) K254211
K254211 is an FDA 510(k) premarket notification submitted by Vesalio, Inc. for the device "pVasc Net Mechanical Thrombectomy Device". The FDA issued a decision of Substantially Equivalent on August 5, 2026. Vesalio, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2026
- Date Received
- December 29, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No