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

Clearance details

Applicant

Cook, Inc.

Product code

Code BTO

Device class

Class 2

Regulation

21 CFR 868.5800

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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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 →