CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved— 510(k) K142934

Substantially Equivalent

Covidien

FDA 510(k) clearance K142934 for CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved, Substantially Equivalent on 2015-06-17. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2014-10-09
Decision date: 2015-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.