510(k) K081467 ยท QEY Mechanical Thrombolysis Catheter
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
| Applicant | Ekos Corp., Bothell WA, US |
| Decision | Substantially Equivalent, Jun 26, 2008 |
| Received | May 27, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081467
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2016 | EKOS Corporation EkoSonic Endovascular Devices
EKOS Intelligent Drug Delivery Catheter Terminated |
KRA | None listed |
| Feb 24, 2016 | EKOS Corporation EkoSonic Endovascular System, Catalog Number 500-56112.
It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (ID Terminated |
KRA | None listed |
| Jul 20, 2015 | EKOS Corporation The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device.
The EkoSonic Endovascular System consists of three mai Terminated |
KRA | None listed |
| Nov 1, 2013 | EKOS Corporation The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peri Terminated |
KRA | None listed |
| Jul 17, 2012 | EKOS Corporation EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusio Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.