A.T.S. 1500 TOURNIQUET— 510(k) K870784

Name: FDA 510(k) clearance K870784
Creator: U.S. Food and Drug Administration
Published: 1987-03-18

Substantially Equivalent

Aspen Laboratories, Inc.

FDA 510(k) clearance K870784 for A.T.S. 1500 TOURNIQUET, Substantially Equivalent on 1987-03-18. Applicant: Aspen Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Aspen Laboratories, Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1987-02-26
Decision date: 1987-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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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.