CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved— 510(k) K142934
Substantially EquivalentCovidien
FDA 510(k) clearance K142934 for CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved, Substantially Equivalent on 2015-06-17. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . 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.