Ekos Corp.
Medical device manufacturer in Bothell, WA.
25510(k) clearances
0PMA approvals
11recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)QEY · Special | 08/17/2020SE |
| K111705 | Ekosonic Endovascular SystemQEY · Traditional | 08/03/2011SE |
| K081467 | Ekosonic Endovascular System with Rapid Pulse ModulationQEY · Special | 06/26/2008SE |
| K080392 | EndoWave Infusion SystemQEY · Special | 04/30/2008SE |
| K073166 | Endowave Infusion SystemKRA · Traditional | 04/22/2008SESU |
| K072507 | Endowave Infusion SystemQEY · Special | 10/04/2007SE |
| K071933 | Endowave Infusion SystemQEY · Special | 08/10/2007SE |
| K063620 | Ekos Micro-Infusion SystemQEY · Traditional | 08/06/2007SESU |
| K062508 | Neurowave Micro-Infusion SystemNUI · Special | 12/05/2006SESU |
| K062507 | Micro-Infusion SystemQEY · Special | 11/22/2006SE |
| K060422 | Lysus Infusion SystemQEY · Special | 03/09/2006SE |
| K060084 | Lysus Infusion SystemQEY · Special | 02/07/2006SE |
| K053437 | Ekos Micro-Infusion SystemNUI · Special | 01/06/2006SE |
| K053432 | Ekos Micro-Infusion SystemQEY · Special | 12/30/2005SE |
| K052071 | Lysus Infusion SystemQEY · Special | 08/16/2005SE |
| K051319 | Lysus Infusion SystemQEY · Special | 06/15/2005SE |
| K051225 | Ekos Micro-Infusion SystemNUI · Special | 06/10/2005SESU |
| K041826 | Ekos Ultrasound Infusion SystemNUI · Traditional | 04/27/2005SESU |
| K050563 | Ekos Peripheral Infusion SystemQEY · Special | 03/29/2005SE |
| K050472 | Lysus Infusion SystemDRA · Special | 03/11/2005SE |
| K043269 | Lysus Infusion SystemQEY · Special | 12/22/2004SE |
| K042456 | Lysus Infusion SystemQEY · Special | 09/23/2004SE |
| K041629 | Lysus Infusion SystemQEY · Traditional | 08/06/2004SE |
| K033214 | Ekos Peripheral Infusion SystemQEY · Special | 10/14/2003SE |
| K030637 | Ekos Peripheral Infusion SystemQEY · Traditional | 07/22/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2890-2016 Class II | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion…Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the… | 08/22/2016Terminated |
| Z-2854-2016 Class II | EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterThe recalling firm identified ten devices which were distributed and could potentially be non-compliant.… | 08/09/2016Terminated |
| Z-0864-2016 Class II | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main…The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery… | 01/21/2016Terminated |
| Z-2148-2015 Class II | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic…The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. | 06/24/2015Terminated |
| Z-0133-2014 Class II | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585…The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is… | 10/02/2013Terminated |
| Z-2023-2012 Class II | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124…EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on… | 05/24/2012Terminated |
| Z-1773-2008 | Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug…Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface… | 04/01/2008Terminated |
| Z-1752-2008 | PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave…Potential for unit to burn patient. | 03/10/2008Terminated |
| Z-1892-2008 | EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound…Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing.… | 02/20/2008Terminated |
| Z-0577-2007 | EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters.…Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery… | 02/09/2007Terminated |
| Z-0195-2007 | Lysus Transport Stand (infusion stand), part number 4896-003Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard. | 10/12/2006Terminated |