SINGLE AND DUAL TOURNIQUET CUFF— 510(k) K860463

Substantially Equivalent

Aspen Laboratories, Inc.

FDA 510(k) clearance K860463 for SINGLE AND DUAL TOURNIQUET CUFF, Substantially Equivalent on 1986-02-25. Applicant: Aspen Laboratories, Inc..

Clearance details

Applicant: Aspen Laboratories, Inc.
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 1986-02-06
Decision date: 1986-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.