Device typeIntracardiac ultrasound imaging catheter, steerable, reprocessed: 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 an ultrasound system for image transmission/display. This is a previously used single-use device that has been processed for an additional single-use patient application.
FDA categoryReprocessed intravascular ultrasound catheter
Device ID00885825020910
Catalog number10438577
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Length90.0 Centimeter