TRAUMAFUSE RAPID INFUSION DEVICE— 510(k) K890077

Substantially Equivalent

The Traumafuse Co.

FDA 510(k) clearance K890077 for TRAUMAFUSE RAPID INFUSION DEVICE, Substantially Equivalent on 1989-04-03. Applicant: The Traumafuse Co..

Clearance details

Applicant: The Traumafuse Co.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1989-01-09
Decision date: 1989-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.