Micro Catheter
K号: K243534 · 2025-07-30
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决定日期2025-07-30
产品代码KRA
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
Micro Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K243534. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Micro Catheter?
Micro Catheter is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K243534.
When did Micro Catheter receive FDA 510(k) clearance?
Micro Catheter received FDA 510(k) clearance on 2025-07-30, under 510(k) number K243534.
Who is the listed applicant for Micro Catheter?
The FDA 510(k) record lists Suzhou Zenith Vascular SciTech Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Micro Catheter?
The FDA product code for Micro Catheter is KRA.
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Suzhou Zenith Vascular SciTech Limited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：KRA）
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。
K253509TriSalus TriNav Advance 注射系统Trisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ 微导管Instylla, Inc.K260771TruSelect™ 2.6 微导管Boston Scientific CorporationK250794InVera 注射器Invera MedicalK231821XO导管微导管（E20-090-S，E20-110-S，E20-130-S，E20-150-S，E20-175-S，E20-220-S，E20-090-B，E20-110-B，E20-130-B，E20-150-B，E20-175-B，E20-220-B，E26-090-S，E26-110-S，E26-130-S，E26-150-S，E26-175-S，E26-220-S，E26-090-B，E26-110-B，E26-130-B，E26-150-B，E26-175-B，E26-220-B）Transit Scientific, 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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