MegaVac Mechanical Thrombectomy System

FDA 510(k) K171493 · Capture Vascular, Inc.

Substantially Equivalent

510(k) numberK171493

Submission

Device name
MegaVac Mechanical Thrombectomy System
Applicant
Capture Vascular, Inc.
Mountain Village, CO, US
Received
May 22, 2017
Decision date
August 10, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEX – Coronary Mechanical Thrombectomy With Aspiration
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.

Other 510(k)s with product code QEX

510(k)DeviceApplicantDecision
K253407NeVa PV Thrombectomy DeviceQEX · Traditional Vesalio, Inc.11/24/2025SESU
K163618INDIGO Aspiration SystemQEX · Traditional Penumbra, Inc.05/24/2017SESU

Questions and answers

When was MegaVac Mechanical Thrombectomy System cleared by the FDA?

MegaVac Mechanical Thrombectomy System (K171493) received a 510(k) decision of Substantially Equivalent on August 10, 2017, 80 days after the submission was received.

What is the product code of K171493?

The FDA product code is QEX – Coronary Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.