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 |