{"publicDeviceRecordKey":"3033879c-75f1-462b-b689-209e9b03bbb1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-04-21T00:00:00.000Z","devicePublishDate":"2017-03-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M732LPBC4560DX1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Lithoplasty®","versionModelNumber":"M732LPBC4560DX1","catalogNumber":"M732LPBC4560DX1","dunsNumber":"055514478","companyName":"Shockwave Medical, Inc.","deviceCount":1,"deviceDescription":"The 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.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-877-775-4846","phoneExtension":null,"email":"cs@shockwavemedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59026","gmdnPTName":"Ultrasound thrombolysis system catheter, peripheral","gmdnPTDefinition":"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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PPN","productCodeName":"Percutaneous Catheter, Ultrasound"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"0.014\" guidewire compatible OTW"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"6 F introducer sheath compatible"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"4.5x60mm balloon size"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"0.064\" folded balloon size"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"110cm working length"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry and deep away from heat."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}