The following data is part of a premarket notification filed by Ekos Corporation with the FDA for Ekosonic Endovascular System.
| Device ID | K111705 |
| 510k Number | K111705 |
| Device Name: | EKOSONIC ENDOVASCULAR SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | EKOS CORPORATION 11911 North Creek Parkway South Bothell, WA 98011 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten EKOS CORPORATION 11911 North Creek Parkway South 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 | 2011-06-17 |
| Decision Date | 2011-08-03 |
| Summary: | summary |