Cleared Traditional

Sangria? Thrombectomy System

K251207 · Avantec Vascular Corporation · Cardiovascular

Jan 2026

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K251207 is an FDA 510(k) clearance for the Sangria? Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Avantec Vascular Corporation (Sunnyvale, US). The FDA issued a Cleared decision on January 7, 2026, 264 days after receiving the submission on April 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K251207 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	January 07, 2026
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEW — Peripheral Mechanical Thrombectomy With Aspiration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.