FDA applicant

Vascular Medcure, Inc.

Anaheim, CA5 decisions2019–20200 recalls

FDA records 5 decisions for Vascular Medcure, Inc. (Anaheim, CA) from 2019 to 2020: 5 510(k) clearances. All are in product code QEW (Peripheral Mechanical Thrombectomy With…). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. 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 Vascular Medcure, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2019high 3 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Vascular Medcure, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Vascular Medcure, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?