K903730

Substantially Equivalent

D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES

Applicant: Concord/Portex
Product code: BTO
Advisory panel: Anesthesiology
Date received: 1990-08-16
Decision date: 1990-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, 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.