510(k) Report

FDA applicant

Cardio-Pak

Billings, MT1 decision1990–19901 recall

FDA records 1 decision for Cardio-Pak (Billings, MT) in 1990: 1 510(k) clearance. All are in product code DXT (Injector And Syringe, Angiographic). 1 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 Cardio-Pak’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio-Pak since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic1decision

What has FDA decided for it lately?

  • K902475Cardio-Pak Angiography Custom PacksCardio-Pak · 19901 recall

The one decision as Cardio-Pak →

What has been recalled?

1 recall linked to its devices; the latest:

  • K902475Custom surgical packs for a variety of surgical applications. Each pack is custom…Mar 25, 2003