PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY— 510(k) K040014

Clearance details

Applicant

Portex , Ltd.

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2003-12-24

Decision date

2004-02-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hyth, Kent, GB

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Death

42

Injury

1,344

Malfunction

5,608

Other

1

Total

6,995

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 →