<?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>ff7522bb-7d6b-4b86-b1dc-893e7c270dbd</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2026-06-22</publicVersionDate><devicePublishDate>2016-03-21</devicePublishDate><deviceCommDistributionEndDate>2026-06-15</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>38033178004498</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08033178004497</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate>2026-06-15</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>BOX</pkgType></identifier><identifier><deviceId>08033178004497</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>Intracardiac Sucker</brandName><versionModelNumber>S352-80</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>442126587</dunsNumber><companyName>SORIN GROUP ITALIA SRL</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K900339</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>34923</gmdnCode><gmdnPTName>Suction system catheter, general-purpose</gmdnPTName><gmdnPTDefinition>A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DTS</productCode><productCodeName>SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>