<?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>86d71006-0ff0-4b07-bba0-5a46bc102d49</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2017-03-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00899054002012</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>Sof-Flo Atraumatic Coronary Artery Shunt</brandName><versionModelNumber>SHT-1215S</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>791048924</dunsNumber><companyName>KDL MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Vessel Shunt 1.50mm Tapered Tip, 12mm Shaft</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>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>972-783-7005</phone><phoneExtension xsi:nil="true"/><email>cust_svc@chasemedical.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K972665</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>47111</gmdnCode><gmdnPTName>Surgical intravascular shunt</gmdnPTName><gmdnPTDefinition>A sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DWF</productCode><productCodeName>Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>