PSM 3-通路硅胶 Foley 导尿管
K号: K181616 · 2018-09-21
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申请人Pathway, LLC
决定日期2018-09-21
产品代码EZL
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
PSM 3-Way Silicone Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pathway, LLC. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181616. 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 PSM 3-Way Silicone Foley Catheter?
PSM 3-Way Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Pathway, LLC. The 510(k) number is K181616.
When did PSM 3-Way Silicone Foley Catheter receive FDA 510(k) clearance?
PSM 3-Way Silicone Foley Catheter received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181616.
Who is the listed applicant for PSM 3-Way Silicone Foley Catheter?
The FDA 510(k) record lists Pathway, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PSM 3-Way Silicone Foley Catheter?
The FDA product code for PSM 3-Way Silicone Foley Catheter is EZL.
相关临床试验
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列明Pathway, 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：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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