The following data is part of a premarket notification filed by Ekos Corp. with the FDA for Modification To Endowave Infusion System.
| Device ID | K080392 |
| 510k Number | K080392 |
| Device Name: | MODIFICATION TO ENDOWAVE INFUSION SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | EKOS CORP. 11911 N CREEK PARKWAY SOUTH Bothell, WA 98011 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten EKOS CORP. 11911 N CREEK PARKWAY SOUTH Bothell, WA 98011 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-04-30 |
| Summary: | summary |