510(k) Report

FDA applicant

Claret Medical, Inc.

Santa Rosa, CA1 decision2017–20170 recalls

FDA records 1 decision for Claret Medical, Inc. (Santa Rosa, CA) in 2017: 1 De Novo grant. All are in product code PUM (Temporary Catheter, Embolic Protection…). 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 Claret Medical, 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 — Claret Medical, 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?

  • PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • DEN160043Sentinel Cerebral Protection SystemClaret Medical, Inc. · 20171cites it

What has FDA decided for it lately?

  • DEN160043Sentinel Cerebral Protection SystemClaret Medical, Inc. · 2017

The one decision as Claret Medical, Inc. →