FDA applicant

Volcano Atheromed, Inc.

Menlo Park, CA7 decisions2014–20210 recalls

FDA records 7 decisions for Volcano Atheromed, Inc. (Menlo Park, CA) from 2014 to 2021: 7 510(k) clearances. Most are in product codes MCW (Catheter, Peripheral, Atherectomy) and QEZ (Aspiration Thrombectomy Catheter). Since 2016 its 510(k)s took a median of 55 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 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 Volcano Atheromed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014high 2 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

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

See the 510(k) Report

Other applicant names beginning “Volcano”

FDA records each applicant name separately; these may or may not be the same firm.

Volcano Corporation 55 Volcano Therapeutics, Inc. 3 Volcano Corporation (Dba Philips Image Guided Therapy… 1

Volcano Atheromed, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Volcano”