Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)— 510(k) K221661

Substantially Equivalent

Compression Works, Inc.

FDA 510(k) clearance K221661 for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S), Substantially Equivalent on 2023-03-03. Applicant: Compression Works, Inc..

Clearance details

Applicant: Compression Works, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2022-06-08
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoover, AL, US

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.