The following data is part of a premarket notification filed by Btg International, Inc. with the FDA for Ekosonic Control Unit 4.0.
| Device ID | K162771 |
| 510k Number | K162771 |
| Device Name: | EkoSonic Control Unit 4.0 |
| Classification | Catheter, Continuous Flush |
| Applicant | BTG International, Inc. 11911 N Creek Pkwy S Bothell, WA 98011 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen BTG International, Inc. 11911 N Creek Pkwy S Bothell, WA 98011 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-02-24 |
| Summary: | summary |