Edwards eSheath+ 引导器套装
K号: K254279 · 2026-04-17
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决定日期2026-04-17
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
Edwards eSheath+ introducer set is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K254279. 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 Edwards eSheath+ introducer set?
Edwards eSheath+ introducer set is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Edwards Lifesciences. The 510(k) number is K254279.
When did Edwards eSheath+ introducer set receive FDA 510(k) clearance?
Edwards eSheath+ introducer set received FDA 510(k) clearance on 2026-04-17, under 510(k) number K254279.
Who is the listed applicant for Edwards eSheath+ introducer set?
The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Edwards eSheath+ introducer set?
The FDA product code for Edwards eSheath+ introducer set 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。
列明Edwards Lifesciences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。
K254232ECLIPTIS 左心耳附壁排除系统 (ECS135)；ECLIPTIS 左心耳附壁排除系统 (ECS140)；ECLIPTIS 左心耳附壁排除系统 (ECS145)；ECLIPTIS 左心耳附壁排除系统 (ECS150)K260105Fogarty 弹簧夹，无手柄夹具和夹具插入物K252533HemoSphere Alta高级监测平台（ALTAALL1; ALTACR1; ALTASR1）K253034HemoSphere Stream模块K252364Edwards eSheath Optima 引导器套装K243781HemoSphere 高级监测仪 (HEM1)；HemoSphere 技术模块 (HEMTOM10)；HemoSphere 清晰视野模块 (HEMCSM10)；智能压力控制器 (PC1Q)；Acumen IQ Plus 指套 (AIQCA2)；HemoSphere 压力电缆 (HEMPSC100)；HemoSphere Vita 监测仪 (HEMVITA1)；HemoSphere Vita 技术模块 (HEMVTOM1)；HemoSphere VitaWave 模块 (HEMVWM1)；VitaWave Plus 指套 (VWCA2)
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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