510(k) Report

FDA applicant

Capture Vascular, Inc.

Mountain Village, CO1 decision2017–20170 recalls

FDA records 1 decision for Capture Vascular, Inc. (Mountain Village, CO) in 2017: 1 510(k) clearance. All are in product code QEX (Coronary Mechanical Thrombectomy With Aspiration). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Capture Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Capture Vascular, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEXCoronary Mechanical Thrombectomy With Aspiration1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171493MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc. · 20173cite it

What has FDA decided for it lately?

  • K171493MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc. · 2017

The one decision as Capture Vascular, Inc. →