VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC— 510(k) K100283

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K100283 for VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC, Substantially Equivalent on 2010-04-23. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2010-02-01
Decision date: 2010-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.