EZ VEIN INFLATABLE TOURNIQUET— 510(k) K112874

Substantially Equivalent

Dominion Medical Devices, LLC

FDA 510(k) clearance K112874 for EZ VEIN INFLATABLE TOURNIQUET, Substantially Equivalent on 2011-10-17. Applicant: Dominion Medical Devices, LLC.

Clearance details

Applicant: Dominion Medical Devices, LLC
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 2011-09-30
Decision date: 2011-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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.