Fogarty 穿透管腔取栓导管
K号: K240078 · 2024-08-28
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决定日期2024-08-28
产品代码DXE
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
Fogarty Thru-Lumen Embolectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K240078. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fogarty Thru-Lumen Embolectomy Catheter?
Fogarty Thru-Lumen Embolectomy Catheter is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K240078.
When did Fogarty Thru-Lumen Embolectomy Catheter receive FDA 510(k) clearance?
Fogarty Thru-Lumen Embolectomy Catheter received FDA 510(k) clearance on 2024-08-28, under 510(k) number K240078.
Who is the listed applicant for Fogarty Thru-Lumen Embolectomy Catheter?
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fogarty Thru-Lumen Embolectomy Catheter?
The FDA product code for Fogarty Thru-Lumen Embolectomy Catheter is DXE.
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, LLC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：DXE）
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。
K241330Fogarty Fortis 动脉取栓导管Edwards LifesciencesK233820Fogarty 动脉取栓导管带门控阀Edwards LifesciencesK233819Fogarty 静脉血栓切除术导管Edwards Lifesciences, LLCK233619Fogarty 螺旋导管；Fogarty 移植物取栓导管Edwards LifesciencesK213771Merlin吸引系统Mivi Neurovascular, Inc.K202049Python 导管/导丝 Latis 移植物清洁导管Applied Medical Resources Corporation
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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