Genie MAX 大口径引导鞘
K号: K253652 · 2026-01-22
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决定日期2026-01-22
产品代码DYB
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]
---
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
Genie MAX Large Bore Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Cultiv8 1, LLC. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K253652. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Genie MAX Large Bore Introducer Sheath?
Genie MAX Large Bore Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Cultiv8 1, LLC. The 510(k) number is K253652.
When did Genie MAX Large Bore Introducer Sheath receive FDA 510(k) clearance?
Genie MAX Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-01-22, under 510(k) number K253652.
Who is the listed applicant for Genie MAX Large Bore Introducer Sheath?
The FDA 510(k) record lists Cultiv8 1, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Genie MAX Large Bore Introducer Sheath?
The FDA product code for Genie MAX Large Bore Introducer Sheath is DYB.
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。
相关器械（代码：DYB）
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。
K253526NAMIC 扩张器和套管Medline Industries, LPK261529微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（SIS05C）；微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（IS01）；引导器套件/微引导器套件/引导器套装/微引导器套装/微引导器鞘套装/引导器鞘套装（NIS04）Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line 可撕开引导器Health Line International CorporationK261492FieldFlex 可弯曲鞘CenterPoint Systems, LLCK260606Echo 大口径引导鞘Echo Medical, LLC
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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