The following data is part of a premarket notification filed by Btg International, Inc. with the FDA for Ekosonic Endovascular Device With Control Unit 4.0.
| Device ID | K183361 |
| 510k Number | K183361 |
| Device Name: | EkoSonic Endovascular Device With Control Unit 4.0 |
| Classification | Catheter, Continuous Flush |
| Applicant | BTG International, Inc. 11911 N Creek Pkwy S Bothell, WA 98011 |
| Contact | Benjamin Hornsey |
| Correspondent | Benjamin Hornsey 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 | 2018-12-04 |
| Decision Date | 2019-04-05 |