510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K171493Substantially Equivalent

MegaVac Mechanical Thrombectomy System

Capture Vascular, Inc., Mountain Village CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171493 is the FDA 510(k) clearance record for MegaVac Mechanical Thrombectomy System, a class II device, cleared for Capture Vascular, Inc. on under FDA product code QEX (Coronary Mechanical Thrombectomy With Aspiration). FDA's definition for product code QEX reads: "To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration". FDA records list one 510(k) clearance for Capture Vascular, Inc. As of , FDA records show no recalls naming K171493.

Clearance record

Decision date
Received
(80 days to decision)
Product code
QEX Coronary Mechanical Thrombectomy With Aspiration
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Capture Vascular, Inc. 620 Mountain Village Blvd., Mountain Village CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEX

Trailing 12 months
1 clearance under product code QEX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QEX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260