The following data is part of a premarket notification filed by Broncus Medical, Inc with the FDA for Easypath Rf Introducer Sheath.
| Device ID | K200702 |
| 510k Number | K200702 |
| Device Name: | EasyPath RF Introducer Sheath |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Broncus Medical, Inc 125 Nicholson Lane San Jose, CA 95134 |
| Contact | Robin Bush |
| Correspondent | Robin Bush Broncus Medical, Inc 125 Nicholson Lane San Jose, CA 95134 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2021-01-14 |