WELL LEAD TRACHEOSTOMY TUBE— 510(k) K042684

Substantially Equivalent

Well Lead Medical Instruments

FDA 510(k) clearance K042684 for WELL LEAD TRACHEOSTOMY TUBE, Substantially Equivalent on 2005-02-17. Applicant: Well Lead Medical Instruments.

Clearance details

Applicant: Well Lead Medical Instruments
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2004-09-29
Decision date: 2005-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo Beach, FL, US

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.