510(k) K042456 ยท QEY Mechanical Thrombolysis Catheter
Lysus Infusion System
| Applicant | Ekos Corp., Bothell WA, US |
| Decision | Substantially Equivalent, Sep 23, 2004 |
| Received | Sep 10, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2005 | Ekos Corp Lysus Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physic Terminated |
KRA | None listed |
| Nov 1, 2005 | Ekos Corp The Lysus Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the del Terminated |
KRA | None listed |
| Nov 1, 2005 | Ekos Corp Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the d Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.