<?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>f947f5e0-e5e9-4560-967c-08047253dc21</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>7</publicVersionNumber><publicVersionDate>2026-04-28</publicVersionDate><devicePublishDate>2015-12-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00810170017933</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>Azur Detachable Helical HydroCoil</brandName><versionModelNumber>45-480610</versionModelNumber><catalogNumber>45-480610</catalogNumber><dunsNumber>003263105</dunsNumber><companyName>Microvention, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Azur</deviceDescription><DMExempt>true</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>true</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(714)247-8000</phone><phoneExtension xsi:nil="true"/><email>customerservice@microvention.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>60941</gmdnCode><gmdnPTName>Non-neurovascular embolization coil</gmdnPTName><gmdnPTDefinition>A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KRD</productCode><productCodeName>Device, Vascular, for Promoting Embolization</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>6 mm x 10 cm</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>