<?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>9cebbe34-9e06-4e95-9c0b-a75e3580be58</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-11-18</publicVersionDate><devicePublishDate>2020-05-29</devicePublishDate><deviceCommDistributionEndDate>2024-11-15</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>H787CT80LPBDNFVI0</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>BioFlo Vortex</brandName><versionModelNumber>CT80LPBDNFVI</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>809699023</dunsNumber><companyName>NAVILYST MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>SmartPort+ Low Profile Port with Endexo and Vortex Technology</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(518)795-1676</phone><phoneExtension xsi:nil="true"/><email>dgreer@angiodynamics.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K190559</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61494</gmdnCode><gmdnPTName>Vascular port/catheter</gmdnPTName><gmdnPTDefinition>A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>LJT</productCode><productCodeName>PORT &amp; CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="2.67"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Catheter Gauge</sizeType><size unit="French" value="8"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="63"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>