510(k) K140151 ยท QEY Mechanical Thrombolysis Catheter
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
| Applicant | Btg International, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, May 21, 2014 |
| Received | Jan 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140151
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.