KALTOSTAT WOUND DRESSING— 510(k) K904488

Substantially Equivalent for Some Indications

Calgon Vestal Div.

FDA 510(k) clearance K904488 for KALTOSTAT WOUND DRESSING, Substantially Equivalent for Some Indications on 1990-12-12. Applicant: Calgon Vestal Div..

Clearance details

Applicant: Calgon Vestal Div.
Product code: Code QSY
Advisory panel: Unknown
Date received: 1990-10-02
Decision date: 1990-12-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.