Company ยท US
Ekos Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2020. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 2020 | K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) Ekos Corporation | QEY |
| Aug 3, 2011 | K111705 | EKOSONIC ENDOVASCULAR SYSTEM Ekos Corporation | QEY |
| Jun 26, 2008 | K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION Ekos Corp. | QEY |
| Apr 30, 2008 | K080392 | EndoWave Infusion System Ekos Corp. | QEY |
| Apr 22, 2008 | K073166 | ENDOWAVE INFUSION SYSTEM Ekos Corp. | KRA |
| Oct 4, 2007 | K072507 | ENDOWAVE INFUSION SYSTEM Ekos Corp. | QEY |
| Aug 10, 2007 | K071933 | ENDOWAVE INFUSION SYSTEM Ekos Corp. | QEY |
| Aug 6, 2007 | K063620 | EKOS MICRO-INFUSION SYSTEM Ekos Corp. | QEY |
| Dec 5, 2006 | K062508 | NEUROWAVE MICRO-INFUSION SYSTEM Ekos Corp. | NUI |
| Nov 22, 2006 | K062507 | MICRO-INFUSION SYSTEM Ekos Corp. | QEY |
| Mar 9, 2006 | K060422 | LYSUS INFUSION SYSTEM Ekos Corp. | QEY |
| Feb 7, 2006 | K060084 | LYSUS INFUSION SYSTEM Ekos Corp. | QEY |
| Jan 6, 2006 | K053437 | EKOS MICRO-INFUSION SYSTEM Ekos Corp. | NUI |
| Dec 30, 2005 | K053432 | EKOS MICRO-INFUSION SYSTEM Ekos Corp. | QEY |
| Aug 16, 2005 | K052071 | LYSUS INFUSION SYSTEM Ekos Corp. | QEY |
| Jun 15, 2005 | K051319 | LYSUS INFUSION SYSTEM Ekos Corp. | QEY |
| Jun 10, 2005 | K051225 | EKOS MICRO-INFUSION SYSTEM Ekos Corp. | NUI |
| Apr 27, 2005 | K041826 | EKOS ULTRASOUND INFUSION SYSTEM Ekos Corp. | NUI |
| Mar 29, 2005 | K050563 | EKOS PERIPHERAL INFUSION SYSTEM Ekos Corp. | QEY |
| Mar 11, 2005 | K050472 | LYSUS INFUSION SYSTEM Ekos Corp. | DRA |
| Dec 22, 2004 | K043269 | Lysus Infusion System Ekos Corp. | QEY |
| Sep 23, 2004 | K042456 | Lysus Infusion System Ekos Corp. | QEY |
| Aug 6, 2004 | K041629 | LYSUS INFUSION SYSTEM Ekos Corp. | QEY |
| Oct 14, 2003 | K033214 | EKOS PERIPHERAL INFUSION SYSTEM Ekos Corp. | QEY |
| Jul 22, 2003 | K030637 | EKOS PERIPHERAL INFUSION SYSTEM Ekos Corp. | QEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2016 | EKOS Corporation The EKOS cart has the catalog number 700-60101.
The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infus Terminated |
FOX | None listed |
| Aug 9, 2016 | EKOS Corporation EkoSonic Endovascular Devices
EKOS Intelligent Drug Delivery Catheter Terminated |
KRA | K081467 K111705 +1 |
| 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 | K081467 K111705 +1 |
| 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 | K081467 K111705 +1 |
| 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 | K081467 K111705 |
| 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 | K081467 K111705 |
| 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 | K072507 |
| 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 | K072507 |
| 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 | K072507 |
| 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 | K060422 |
| Nov 16, 2006 | Ekos Corp Lysus Transport Stand (infusion stand), part number 4896-003 Terminated |
FDX | None listed |
| 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 | K042456 |
| 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 | K042456 |
| 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 | K042456 |