Radial Artery Compression Tourniquets— 510(k) K222182

Substantially Equivalent

Beijing Demax Medical Technology Co.,Ltd

FDA 510(k) clearance K222182 for Radial Artery Compression Tourniquets, Substantially Equivalent on 2023-01-04. Applicant: Beijing Demax Medical Technology Co.,Ltd.

Clearance details

Applicant: Beijing Demax Medical Technology Co.,Ltd
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2022-07-22
Decision date: 2023-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.