Cleared Traditional

NeVa PV Thrombectomy Device

K253407 · Vesalio, Inc. · Cardiovascular
Nov 2025
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K253407 is an FDA 510(k) clearance for the NeVa PV Thrombectomy Device, a Coronary Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEX), submitted by Vesalio, Inc. (San Diego, US). The FDA issued a Cleared decision on November 24, 2025, 55 days after receiving the submission on September 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K253407 FDA.gov
FDA Decision Cleared SESU
Date Received September 30, 2025
Decision Date November 24, 2025
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEX — Coronary 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 Coronary Vasculature Through Aspiration.