一次性使用硅胶Foley导尿管
K号: K172807 · 2018-06-04
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决定日期2018-06-04
产品代码EZL
咨询委员会GU
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决定实质等同
器械摘要
Silicone Foley Catheter for single use is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. It received FDA 510(k) clearance on 2018-06-04 under 510(k) number K172807. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Silicone Foley Catheter for single use?
Silicone Foley Catheter for single use is a medical device that received FDA 510(k) clearance on 2018-06-04. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. The 510(k) number is K172807.
When did Silicone Foley Catheter for single use receive FDA 510(k) clearance?
Silicone Foley Catheter for single use received FDA 510(k) clearance on 2018-06-04, under 510(k) number K172807.
Who is the listed applicant for Silicone Foley Catheter for single use?
The FDA 510(k) record lists Changzhou Rongxin Medicine Minimal Invasion Technology as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Silicone Foley Catheter for single use?
The FDA product code for Silicone Foley Catheter for single use is EZL.
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。
相关器械（代码：EZL）
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。
K260756创伤卫士腹部压力感应系统（000-0221）Sentinel Medical Technologies,K262056Rusch 液体金福来尿管Teleflex Medical Sdn. Bhd.K252537Rusch 软塑 Foley 导尿管Teleflex Medical Sdn. Bhd.K243011硅胶尿道导管（硅胶尿道导管）Guangdong Ecan Medical Co., Ltd.K241424InnoCare 专业 Foley 导尿管Innocare Urologics, LLCK232469Rüsch 橡胶金 Foley 导尿管Teleflexmedical, Inc.
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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