GORE® ACUSEAL 血管移植物
K号: K231505 · 2023-06-23
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决定日期2023-06-23
产品代码DSY
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
GORE® ACUSEAL Vascular Graft is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K231505. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GORE® ACUSEAL Vascular Graft?
GORE® ACUSEAL Vascular Graft is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K231505.
When did GORE® ACUSEAL Vascular Graft receive FDA 510(k) clearance?
GORE® ACUSEAL Vascular Graft received FDA 510(k) clearance on 2023-06-23, under 510(k) number K231505.
Who is the listed applicant for GORE® ACUSEAL Vascular Graft?
The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GORE® ACUSEAL Vascular Graft?
The FDA product code for GORE® ACUSEAL Vascular Graft is DSY.
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W. L. Gore & Associates, 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：DSY）
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。
K252445Fusion Bioline血管移植物Maquet Cardiovascular, LLCK252277Spiral Laminar Flow® Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT 血管移植物，Flixene 血管移植物Atrium Medical CorporationK240083GORE® PROPATEN® 血管移植物W. L. Gore & Associates, Inc.
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。
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