The following data is part of a premarket notification filed by Covidien with the FDA for Crosscountry Transbronchial Access Tool Straight, Crosscountry Transbronchial Access Tool Curved.
| Device ID | K142934 |
| 510k Number | K142934 |
| Device Name: | CrossCountry Transbronchial Access Tool Straight, CrossCountry Transbronchial Access Tool Curved |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | COVIDIEN 161 Cheshire Lane Suite 100 Plymouth, MN 55441 |
| Contact | Deborah Fleetham |
| Correspondent | Deborah Fleetham COVIDIEN 161 Cheshire Lane Suite 100 Plymouth, MN 55441 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-09 |
| Decision Date | 2015-06-17 |
| Summary: | summary |