{"publicDeviceRecordKey":"e24a3682-c22c-4e96-9af3-5af34f2c6591","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2022-11-09T00:00:00.000Z","devicePublishDate":"2016-09-05T00:00:00.000Z","deviceCommDistributionEndDate":"2018-12-02T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M20650600","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Pronto® XL extraction catheter","versionModelNumber":"5060","catalogNumber":null,"dunsNumber":"008999906","companyName":"Vascular Solutions, Inc.","deviceCount":1,"deviceDescription":"The 7F PRONTO XL extraction catheter is indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system and the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arteriovenous fistulas.\n","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":"888-240-6001","phoneExtension":null,"email":"customerservice@vasc.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58173","gmdnPTName":"Thrombectomy suction catheter","gmdnPTDefinition":"A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DXE","productCodeName":"Catheter, Embolectomy"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"7"},"sizeText":null,"sizeString":"Catheter Gauge: 7 French"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Straight Tip"}]},"environmentalConditions":{"storageHandling":[]},"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":[]}}