TRACHEAL TUBE FIXATION DEVICE— 510(k) K843790

Substantially Equivalent

Laerdal California, Inc.

FDA 510(k) clearance K843790 for TRACHEAL TUBE FIXATION DEVICE, Substantially Equivalent on 1985-03-11. Applicant: Laerdal California, Inc..

Clearance details

Applicant: Laerdal California, Inc.
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1984-09-27
Decision date: 1985-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, 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.