MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)— 510(k) K080339

Clearance details

Applicant

Medsource International, LLC

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

2008-02-08

Decision date

2008-10-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indianapolis, IN, US

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Death

92

Injury

1,263

Malfunction

7,475

Other

2

Total

8,832

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 →