FDA applicant

Avenu Medical, Inc.

San Juan Capistrano, CA4 decisions2018–20190 recalls

FDA records 4 decisions for Avenu Medical, Inc. (San Juan Capistrano, CA) from 2018 to 2019: 3 510(k) clearances and 1 De Novo grant. All are in product code PQK (Percutaneous Catheter For Creation Of An…). Its devices cite 3 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Avenu Medical”.

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 Avenu Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2018high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Avenu Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avenu Medical, 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

Avenu Medical, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?