TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE— 510(k) K894721

Name: FDA 510(k) clearance K894721
Creator: U.S. Food and Drug Administration
Published: 1989-10-20

Substantially Equivalent

The Traumafuse Co.

FDA 510(k) clearance K894721 for TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE, Substantially Equivalent on 1989-10-20. Applicant: The Traumafuse Co.. Device class: 2.

Clearance details

Applicant: The Traumafuse Co.
Product code: Code DWE
Device class: Class 2
Regulation: 21 CFR 870.4390
Advisory panel: Cardiovascular
Date received: 1989-07-25
Decision date: 1989-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from The Traumafuse Co.

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K895162 — TRAUMAFUSE TRACH SHIELD1990-01-09
K895132 — CONNELL-STEPHENS ENDO ANESS TUBE1989-10-13
K890077 — TRAUMAFUSE RAPID INFUSION DEVICE1989-04-03

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.