Ekos Corp

Serial #s 040914006-004, 040914006-008, 040914007-006, 040914008-003, 040928003-002, 040928003-005, 040928003-009, 040928004-002, 040928005-004, 040928006-002, 040928006-003, 040928006-006, 041013005-004, 040702005-007, 040702005-008, 040719001-005, 040719001-006, 040913002-001, 040913002-002, 040913002-003, 040914007-002, 040914010-001, 040928004-005, 041013006-014, 040928003-012, 040928003-013, 041013005-006, 041013005-007, 041013006-011, 041013006-017, 040719002-003, 040322001-003, 040322001-006, 040322001-013, 040420001-001, 040420001-002, 040420001-004, 040420001-005, 040420001-006, 040420001-007, 040420001-008, 040420001-009, 040420001-010, 040420001-011, 040702005-001, 040702005-002, 040702006-001, 040702006-002, 040928004-004, 040928005-002, 040928005-005, 040928006-004, 040928006-005, 040702005-003, 040702005-004, 040702006-003, 040702006-004, 040719001-001, 040719001-002, 040719002-002, 040719003-001, 040719003-002, 040914007-005, 040914008-002, 040914009-003, 040928004-001, 040928006-009, 040928006-010, 040928007-002, 040702005-005, 040702005-006, 040702006-005, 040719001-003, 040719001-004, 040909003-001, 040909003-002, 040913002-004, 040913002-005, 040914006-007, 040914007-003, 040914007-004, 040914009-004, 040928003-001, 040928004-008, 040928005-006, 040928006-001, 040928007-001, 041013005-005, 041013006-012, 041013006-013, 041119002-001, 041119003-001, 040719001-007, 040914006-003, 040914007-001, 040914008-001, 040914009-001, 040928003-010, 040928004-006, 040928004-007, 041013004-001, 041013004-002, 041013004-003, 041013006-008, 041013006-015, 040420001-003, 040719001-008, 040719002-001, 040914006-001, 040914006-005, 040914006-006, 040914006-009, 040914006-010, 040914008-004, 040928003-003, 040928003-004, 040928003-011, 040928003-014, 040928004-003, 040928005-007, 040928005-008, 041013006-009, 041013006-016, 041013006-018, 050204002-001, 050204002-002, 050204002-003, 050204002-004, 050204002-005, 050209002-001, 050209002-002, 050209002-003, 050209002-004, 050209002-005   Catalog # & Part #: 500-52112, 3383-002; 500-52124, 3393-004; 500-52124, 3393-006; 500-52150, 3393-007

Cardiovascular Devices

2

No

Kits were distributed to 6 hospitals in the US, 1 each located in AZ, OH, WA, FL, IL, and CA. The firm also distributed to a customer in Germany.

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 delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) || The Lysus¿ Infusion System consists of three main components, a single use Lysus¿ Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus¿ Infusion Catheter System.

Serial numbers PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014

Cardiovascular Devices

2

No

The device was distributed to 6 hospitals/medical centers; 1 each located in AZ, OH, WA, FL, IL, and. CA. One consignee is located Germany.

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 physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) || The Lysus¿ Infusion System consists of three main components, a single use Lysus¿ Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus¿ Infusion Catheter System.

Serial numbers: 10098-012, 10098-011, 10098-055 Part number: 3929-001 Catalog number: 700-10301

Cardiovascular Devices

2

No

Units were shipped to hospitals, one each in WA, AZ, and OH.

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 delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) || The Lysus¿ Infusion System consists of three main components, a single use Lysus¿ Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus¿ Infusion Catheter System.

060113010-001, 060113010-002, 060113010-003, 060113010-004, 060113010-005, 060113010-006,  060113010-007, 060113010-008, 060113010-009,  060113010-010, 060113010-011, 060113010-012, 060113010-013, 060113010-014, 060113010-015,  060324025-001, 060324025-002  The additional carts do not contain any type of serial number.

Gastroenterology-Urology Devices

2

No

Nationwide.

Lysus Transport Stand (infusion stand), part number 4896-003