PathBuilder 经房间隔穿刺针
K号: K212625 · 2022-03-23
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决定日期2022-03-23
产品代码DRC
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
PathBuilder Transseptal Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K212625. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PathBuilder Transseptal Needle?
PathBuilder Transseptal Needle is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212625.
When did PathBuilder Transseptal Needle receive FDA 510(k) clearance?
PathBuilder Transseptal Needle received FDA 510(k) clearance on 2022-03-23, under 510(k) number K212625.
Who is the listed applicant for PathBuilder Transseptal Needle?
The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PathBuilder Transseptal Needle?
The FDA product code for PathBuilder Transseptal Needle is DRC.
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Shanghai Microport EP Medtech Co., Ltd.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：DRC）
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。
K240246Accusafe 经隔膜导丝 (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp 经隔膜针（CLICK071，CLICK171，CLICK098，CLICK198）Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® 经隔膜导丝（SS-140）Pressure Products Medical Device Manufacturing, LLCK210328SafeSept 钝头针Pressure Products Medical Device Manufacturing, LLCK172950TSN 腱间针Pressure Products Medical Device Manufacturing, LLCK172934无针经房间隔导管Pressure Products Medical Device Manufacturing, 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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