510(k) Report

FDA applicant

Cardeon Corp.

Cupertino, CA6 decisions2000–20040 recalls

FDA records 6 decisions for Cardeon Corp. (Cupertino, CA) from 2000 to 2004: 6 510(k) clearances. All are in product code DWF (Catheter, Cannula And Tubing, Vascular…). 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 Cardeon Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardeon Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardeon Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardeon Corp.’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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