D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES— 510(k) K903730

Substantially Equivalent

Concord/Portex

FDA 510(k) clearance K903730 for D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES, Substantially Equivalent on 1990-09-25. Applicant: Concord/Portex.

Clearance details

Applicant: Concord/Portex
Product code: 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

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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.