DeviceClearance

pVasc Net Mechanical Thrombectomy Device— 510(k) K254211

Substantially Equivalent

Vesalio, Inc.

FDA 510(k) clearance K254211 for pVasc Net Mechanical Thrombectomy Device, Substantially Equivalent on 2026-08-05. Applicant: Vesalio, Inc..

Summary

Vesalio's pVasc Net Mechanical Thrombectomy Device has no product code in this record. The record also gives no model numbers.

The record gives no device class and no regulation number, and the classification panel is listed as Unknown. The Cardiovascular review panel handled it as a Special 510(k).

Vesalio filed from San Diego, California. The substantially equivalent decision came 219 calendar days after receipt (December 29, 2025 to August 5, 2026).

Clearance details

Applicant
Vesalio, Inc.
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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