510(k) K060422 ยท QEY Mechanical Thrombolysis Catheter
LYSUS INFUSION SYSTEM
| Applicant | Ekos Corp., Bothell WA, US |
| Decision | Substantially Equivalent, Mar 9, 2006 |
| Received | Feb 17, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060422
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2007 | Ekos Corp EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA
Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS Endo Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.