Cleared Special

K171493 - MegaVac Mechanical Thrombectomy System

K171493 is an FDA 510(k) clearance for MegaVac Mechanical Thrombectomy System, manufactured by Capture Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code QEX cleared through the Special 510(k) pathway after a 80-day FDA review.

K171493 · Capture Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
80d
Days
Class 2
Risk

K171493 is an FDA 510(k) clearance for the MegaVac Mechanical Thrombectomy System. Classified as Coronary Mechanical Thrombectomy With Aspiration (product code QEX), Class II - Special Controls.

Submitted by Capture Vascular, Inc. (Mountain Village, US). The FDA issued a Cleared decision on August 10, 2017 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K171493

510(k) Number K171493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

QEX Device Classification - Class 2, Special Controls

Product Code QEX Coronary Mechanical Thrombectomy With Aspiration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.