PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS— 510(k) K022212

Substantially Equivalent

Mentor Medical Limited

FDA 510(k) clearance K022212 for PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS, Substantially Equivalent on 2003-03-21. Applicant: Mentor Medical Limited.

Clearance details

Applicant: Mentor Medical Limited
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2002-07-08
Decision date: 2003-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hyth, Kent, GB

Download summary PDF View on FDA.gov ↗

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.