Device typeUltrasound thrombolysis system catheter, peripheral: A flexible tube designed for the percutaneous intravascular administration of high-frequency, low-energy ultrasound and drugs [e.g., tissue plasminogen activator (tPA)] for the disruption of clotted blood (i.e., a thrombus or thromboembolus) in a peripheral artery. It typically consists of a side-hole drug infusion catheter with a multi-element ultrasound core wire. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It is a component of a system that includes a control unit to deliver the ultrasound. This is a single-use device.
FDA categoryPercutaneous Catheter, Ultrasound
Device IDM732LPBC5060DX1
Catalog numberM732LPBC5060DX1
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size"0.014"" guidewire compatible OTW"
Size6 F introducer sheath compatible
Size5.0x60mm balloon size
Size"0.064"" folded balloon OD"
Size110cm working length