ReTrace 肾盂输尿管通道鞘
K号: K181811 · 2018-09-07
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决定日期2018-09-07
产品代码FED
咨询委员会GU
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决定实质等同
器械摘要
ReTrace Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181811. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ReTrace Ureteral Access Sheath?
ReTrace Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Coloplast A/S. The 510(k) number is K181811.
When did ReTrace Ureteral Access Sheath receive FDA 510(k) clearance?
ReTrace Ureteral Access Sheath received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181811.
Who is the listed applicant for ReTrace Ureteral Access Sheath?
The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ReTrace Ureteral Access Sheath?
The FDA product code for ReTrace Ureteral Access Sheath is FED.
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Coloplast A/S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：FED）
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。
K260512一次性输尿管通道鞘Yangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder 内窥镜外管Neptune Medical, Inc.K260410单次使用输尿管通道鞘Zhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex 肾盂输尿管通路鞘套装Boston Scientific CorporationK260965CVAC吸引系统Calyxo, Inc.K260521ClearEVAC输尿管吸引接入鞘（PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250）Zhuhai Pusen Medical Technology Co., Ltd.
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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