The following data is part of a premarket notification filed by Broncus Medical, Inc with the FDA for Empower Rf Catheter.
Device ID | K183240 |
510k Number | K183240 |
Device Name: | Empower RF Catheter |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Broncus Medical, Inc 125 Nicholson Lane San Jose, CA 95134 |
Contact | Aradhana Dhanabalan |
Correspondent | Aradhana Dhanabalan Broncus Medical, Inc 125 Nicholson Lane San Jose, CA 95134 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-11-20 |
Decision Date | 2019-02-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00856571007241 | K183240 | 000 |