FDA applicant

Cardiac Assist Devices, Inc.

Cleveland, OH3 decisions1997–20020 recalls

FDA records 3 decisions for Cardiac Assist Devices, Inc. (Cleveland, OH) from 1997 to 2002: 3 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DTG (Magnet, Test, Pacemaker). Its devices cite 5 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 Cardiac Assist Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiac Assist Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cardiac Assist Devices, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?