XenoSure Dura 生物贴
K号: K183513 · 2019-06-13
广告
决定日期2019-06-13
产品代码GXQ
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
XenoSure Dura Biologic Patch is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K183513. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XenoSure Dura Biologic Patch?
XenoSure Dura Biologic Patch is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K183513.
When did XenoSure Dura Biologic Patch receive FDA 510(k) clearance?
XenoSure Dura Biologic Patch received FDA 510(k) clearance on 2019-06-13, under 510(k) number K183513.
Who is the listed applicant for XenoSure Dura Biologic Patch?
The FDA 510(k) record lists LeMaitre Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XenoSure Dura Biologic Patch?
The FDA product code for XenoSure Dura Biologic Patch is GXQ.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明LeMaitre Vascular, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GXQ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K251191胶原Dura再生膜 - 修复Collagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK172603Cerafix Dura SubstituteAcera Surgical, Inc.K163456DuraGen Secure硬脑膜再生基质Integra LifeSciences Corporation
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告