510(k) Report

FDA applicant

Cardiotech Intl.

Arvada, CO1 decision2002–20020 recalls

FDA records 1 decision for Cardiotech Intl. (Arvada, CO) in 2002: 1 510(k) clearance. All are in product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 1 predicate, 0 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

How often FDA has decided Cardiotech Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiotech Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardiotech Intl.’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

Which product codes does it file in?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K022584Cardiotech Antibotic Hydrogel Wound DressingCardiotech Intl. · 20021cites it

What has FDA decided for it lately?

  • K022584Cardiotech Antibotic Hydrogel Wound DressingCardiotech Intl. · 2002

The one decision as Cardiotech Intl. →