FDA.report

510(k) K142934

Device
CrossCountry Transbronchial Access Tool Straight, CrossCountry Transbronchial Access Tool Curved
Applicant
COVIDIEN
510(k) number
K142934
Product code
EOQ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-06-17
Date received
2014-10-09
Regulation
874.4680
Classification name
Bronchoscope (flexible Or Rigid)
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Deborah Fleetham
Address
161 Cheshire Ln., Suite 100 Plymouth MN US 55441 55441

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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