Pounce™ Sheath
K号: K231828 · 2023-09-07
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决定日期2023-09-07
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
Pounce™ Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231828. 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 Pounce™ Sheath?
Pounce™ Sheath is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Surmodics,Inc.. The 510(k) number is K231828.
When did Pounce™ Sheath receive FDA 510(k) clearance?
Pounce™ Sheath received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231828.
Who is the listed applicant for Pounce™ Sheath?
The FDA 510(k) record lists Surmodics,Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pounce™ Sheath?
The FDA product code for Pounce™ 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。
列明Surmodics,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：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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