TRACHEOTOMY TUBES— 510(k) K781729

Substantially Equivalent

Tracoe Medical GmbH

FDA 510(k) clearance K781729 for TRACHEOTOMY TUBES, Substantially Equivalent on 1978-10-24. Applicant: Tracoe Medical GmbH.

Clearance details

Applicant: Tracoe Medical GmbH
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1978-10-10
Decision date: 1978-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D 6367 Karben 2, DE

Download summary PDF View on FDA.gov ↗

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.