Cleared Traditional

Vesalio Peripheral System

K251312 · Vesalio, Inc. · Cardiovascular

Oct 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K251312 is an FDA 510(k) clearance for the Vesalio Peripheral System, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Vesalio, Inc. (San Diego, US). The FDA issued a Cleared decision on October 24, 2025, 179 days after receiving the submission on April 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K251312 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2025
Decision Date	October 24, 2025
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.