AcuNav Lumos 4D ICE catheter

AcuNav Lumos 4D ICE catheter - 11658641

A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.

• Catheter Gauge: 12.5 French

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: OBJ

Device Name: Catheter, Ultrasound, Intravascular

Device Class: 2

Physical State: Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.

Definition: For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cardiovascular anatomy and physiology.

Regulation Number: 870.1200

Third Party Flag: N

Medical Specialty: CV

Device Id: 04056869997445

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A