<?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>b2f44b0b-1d6e-4f3e-b2ba-fb83a6bdbf4c</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2022-09-27</publicVersionDate><devicePublishDate>2018-01-24</devicePublishDate><deviceCommDistributionEndDate>2020-01-02</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B139WV03401</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>JETi Saline Drive Unit</brandName><versionModelNumber>WV0340</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>034774488</dunsNumber><companyName>WALK VASCULAR L.L.C.</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</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/><gmdnTerms><gmdn><gmdnCode>58214</gmdnCode><gmdnPTName>Mechanical atherectomy/thrombectomy drive system</gmdnPTName><gmdnPTDefinition>A multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy and/or thrombectomy catheter (not included) during an intravascular recanalization procedure. It typically consists of an electrically-powered control unit that supplies the drive motor with electricity to power the catheter and a handpiece with hand-switch that includes the drive motor (for catheter manipulation); a foot-switch may also be included. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DXE</productCode><productCodeName>Catheter, Embolectomy</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>