K092886

Substantially Equivalent

WELL LEAD ENDOBRONCHIAL TUBES

Applicant: Well Lead Instruments
Product code: CBI
Advisory panel: Anesthesiology
Date received: 2009-09-21
Decision date: 2010-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo Beach, FL, US

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.