TRACHE-TITE— 510(k) K950930

Substantially Equivalent

The Varner Group, Inc.

FDA 510(k) clearance K950930 for TRACHE-TITE, Substantially Equivalent on 1995-03-22. Applicant: The Varner Group, Inc..

Clearance details

Applicant: The Varner Group, Inc.
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1995-03-01
Decision date: 1995-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

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.