Cleared Special

K254211 - pVasc Net Mechanical Thrombectomy Device

K254211 · Vesalio, Inc. · Cardiovascular device
Download Printable Device Report (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.

View all Vesalio, Inc. devices

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 -