5a6e7893-ffe7-4e46-a843-7bdfa748842bUpdatePublished42021-04-212017-03-09In Commercial DistributionM732LPBC5060DX1PrimaryHIBCCLithoplasty®M732LPBC5060DX1M732LPBC5060DX1055514478Shockwave Medical, Inc.1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-877-775-4846cs@shockwavemedical.com59026Ultrasound thrombolysis system catheter, peripheralA 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.falseActivePPNPercutaneous Catheter, UltrasoundDevice Size Text, specify0.014" guidewire compatible OTWDevice Size Text, specify6 F introducer sheath compatibleDevice Size Text, specify5.0x60mm balloon sizeDevice Size Text, specify0.064" folded balloon ODDevice Size Text, specify110cm working lengthSpecial Storage Condition, SpecifyKeep dry and keep away from heat.truefalse