<?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>60b1d347-4f06-45c6-9c42-54535e735460</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2018-09-24</publicVersionDate><devicePublishDate>2016-08-19</devicePublishDate><deviceCommDistributionEndDate>2018-09-24</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B09927001200</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>TUBBS MITRAL VALVE DILATOR</brandName><versionModelNumber>2700-120</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>040729840</dunsNumber><companyName>SONTEC INSTRUMENTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>TUBBS MITRAL VALVE DILATOR 
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</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>303-790-9411</phone><phoneExtension xsi:nil="true"/><email>info@sontecinstruments.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K100518</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>11255</gmdnCode><gmdnPTName>Mitral valve dilator</gmdnPTName><gmdnPTDefinition>A hand-operated surgical instrument with specially designed expanding blades designed to dilate mitral stenosis during mitral valve surgery. It typically has forceps-like handles that include an adjustable, self-retaining mechanism to hold the blades at the desired expanded position. It is typically made of high-grade stainless steel and is available in various sizes. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DWP</productCode><productCodeName>Dilator, Vessel, Surgical</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="8"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod><sterilizationMethod>Dry Heat Sterilization</sterilizationMethod></methodTypes></sterilization></device>