FDA applicant

Atheromed, Inc.

Menlo Park, CA2 decisions2014–20140 recalls

FDA records 2 decisions for Atheromed, Inc. (Menlo Park, CA) in 2014: 2 510(k) clearances. All are in product code MCW (Catheter, Peripheral, Atherectomy). Its devices cite 11 predicates, 1 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 Atheromed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Atheromed, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Atheromed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Atheromed, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?