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 |