TRACHEOSTOMA VENT— 510(k) K810436

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K810436 for TRACHEOSTOMA VENT, Substantially Equivalent on 1981-03-04. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1981-02-19
Decision date: 1981-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.