Cleared Special

MegaVac Mechanical Thrombectomy System

K171493 · Capture Vascular, Inc. · Cardiovascular
Aug 2017
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K171493 is an FDA 510(k) clearance for the MegaVac Mechanical Thrombectomy System, a Coronary Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEX), submitted by Capture Vascular, Inc. (Mountain Village, US). The FDA issued a Cleared decision on August 10, 2017, 80 days after receiving the submission on May 22, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K171493 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2017
Decision Date August 10, 2017
Days to Decision 80 days
Submission Type Special
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.