FIXATION DEVICE, TRACH TUBE— 510(k) K882694

Substantially Equivalent

Bioseal

FDA 510(k) clearance K882694 for FIXATION DEVICE, TRACH TUBE, Substantially Equivalent on 1988-08-15. Applicant: Bioseal.

Clearance details

Applicant: Bioseal
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1988-06-27
Decision date: 1988-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, 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.