510(k) K894721— TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE

Substantially Equivalent

The Traumafuse Co.

Clearance details

Applicant: The Traumafuse Co.
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 1989-07-25
Decision date: 1989-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.