510(k) K072507 ยท QEY Mechanical Thrombolysis Catheter
ENDOWAVE INFUSION SYSTEM
| Applicant | Ekos Corp., Bothell WA, US |
| Decision | Substantially Equivalent, Oct 4, 2007 |
| Received | Sep 6, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | EKOS Corporation EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of Terminated |
KRA | None listed |
| Sep 2, 2008 | EKOS Corporation PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised Terminated |
KRA | None listed |
| Aug 20, 2008 | EKOS Corporation Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.