CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING— 510(k) K022584

Name: FDA 510(k) clearance K022584
Creator: U.S. Food and Drug Administration
Published: 2002-12-30

Substantially Equivalent

Cardiotech Intl.

FDA 510(k) clearance K022584 for CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING, Substantially Equivalent on 2002-12-30. Applicant: Cardiotech Intl.. Device class: Unclassified.

Clearance details

Applicant: Cardiotech Intl.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2002-08-05
Decision date: 2002-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

Download summary PDF View on FDA.gov ↗

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K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION2005-07-19
K041268 — SILVERSITE OR CALGITROL2004-09-20
K040019 — SILVERSEAL2004-07-23

Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.