P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)— 510(k) K032112

Clearance details

Applicant

Portex , Ltd.

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

2003-07-09

Decision date

2004-01-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

England Ct21 6db, GB

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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 →