PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT— 510(k) K083031

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K083031 for PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT, Substantially Equivalent on 2009-08-18. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2008-10-10
Decision date: 2009-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hythe, Kent, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.