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    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 infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·May 24, 2012

    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 peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·October 2, 2013

    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 infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

    FDA Recall
    Terminated ·EKOS Corporation·Product code FOX·August 22, 2016

    EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150

    FDA Recall
    Terminated ·Ekos Corp·Product code KRA·February 9, 2007

    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 (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·January 21, 2016

    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·September 28, 2016

    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 infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·July 25, 2012

    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 main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·July 29, 2015

    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 infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·October 5, 2016

    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 peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·November 13, 2013

    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 (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·March 2, 2016

    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 of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·March 10, 2008

    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. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·April 1, 2008

    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 physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·February 20, 2008

    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 main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·June 24, 2015

    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter

    FDA Recall
    Terminated ·EKOS Corporation·Product code KRA·August 9, 2016