Device typeIntravascular ultrasound imaging catheter, single-use: A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.
FDA categoryEchocardiograph, Transducer, ultrasonic, diagnostic
Device ID08714729982500
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter