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

Substantially Equivalent

Portex , Ltd.

FDA 510(k) clearance K040014 for PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY, Substantially Equivalent on 2004-02-13. Applicant: Portex , Ltd..

Clearance details

Applicant: Portex , Ltd.
Product code: Code JOH
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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Adverse events under product code JOH

product code JOH

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.