FDA 510(k)

Rusch Simplastic Foley 导管

K号: K162989 · 2017-02-24

决定日期2017-02-24

产品代码EZL

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决定实质等同

器械摘要

Rusch Simplastic Foley Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162989. 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 Rusch Simplastic Foley Catheters?

Rusch Simplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162989.

When did Rusch Simplastic Foley Catheters receive FDA 510(k) clearance?

Rusch Simplastic Foley Catheters received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162989.

Who is the listed applicant for Rusch Simplastic Foley Catheters?

The FDA 510(k) record lists Teleflexmedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rusch Simplastic Foley Catheters?

The FDA product code for Rusch Simplastic Foley Catheters is EZL.

列明Teleflexmedical, Inc.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。

K232469Rüsch 橡胶金 Foley 导尿管 K212077Teleflex Rusch SoftSimplastic Foley 导尿管 K192324Sheridan 螺旋柔性气管插管 K182847Hudson RCI Voldyne 体积训练器 K181979Rusch FloCath 快速 18 Fr. 弯曲型亲水间歇性导管 K183461Rusch 亲水间歇性导管，Rusch MMG 亲水间歇性导管

查看所有 19 个设备 →

官方来源

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