The following data is part of a premarket notification filed by Ekos Corp. with the FDA for Lysus Infusion System.
| Device ID | K060422 |
| 510k Number | K060422 |
| Device Name: | LYSUS INFUSION SYSTEM |
| Classification | Mechanical Thrombolysis Catheter |
| Applicant | EKOS CORP. 22030 20TH AVENUE S.E. SUITE 101 Bothell, WA 98021 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten EKOS CORP. 22030 20TH AVENUE S.E. SUITE 101 Bothell, WA 98021 |
| Product Code | QEY |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-17 |
| Decision Date | 2006-03-09 |
| Summary: | summary |