Cleared Special

K254211 - pVasc Net Mechanical Thrombectomy Device

K254211 · Vesalio, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
219d
Days
-
Risk

K254211 is an FDA 510(k) clearance for the pVasc Net Mechanical Thrombectomy Device.

Submitted by Vesalio, Inc. (San Diego, US). The FDA issued a Cleared decision on August 5, 2026 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K254211

510(k) Number K254211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date August 05, 2026
Days to Decision 219 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Modification to existing cleared device.

Device Classification - Class ,

Product Code -
Device Class -
K254211 · pVasc Net Mechanical Thrombectomy Device
Download PDF FDA Summary Vesalio, Inc.