K051587

Substantially Equivalent

TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

Applicant: Tracoe Medical GmbH
Product code: BTO
Advisory panel: Anesthesiology
Date received: 2005-06-15
Decision date: 2005-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

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.