<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>e1e848e6-eca6-4f2c-9eb8-cd4e0a125cb2</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2025-08-13</publicVersionDate><devicePublishDate>2016-04-07</devicePublishDate><deviceCommDistributionEndDate>2025-08-11</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00847536020719</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>SolitiareTM</brandName><versionModelNumber>SFR2-4-20</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>826110710</dunsNumber><companyName>Micro Therapeutics, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>STENT SFR2-4-20 V01 US</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)633-8766</phone><phoneExtension xsi:nil="true"/><email>Corporate.UDI@medtronic.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K123378</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>58173</gmdnCode><gmdnPTName>Thrombectomy suction catheter</gmdnPTName><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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NRY</productCode><productCodeName>CATHETER, THROMBUS RETRIEVER</productCodeName></fdaProductCode><fdaProductCode><productCode>POL</productCode><productCodeName>Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Store in a dry, cool place</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Ethylene Oxide</sterilizationMethod></methodTypes></sterilization></device>