FDA 510(k)

Rüsch 橡胶金 Foley 导尿管

K号: K232469 · 2024-08-01

决定日期2024-08-01

产品代码EZL

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决定实质等同

器械摘要

Rüsch Latex Gold Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K232469. 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 Rüsch Latex Gold Foley Catheter?

Rüsch Latex Gold Foley Catheter is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K232469.

When did Rüsch Latex Gold Foley Catheter receive FDA 510(k) clearance?

Rüsch Latex Gold Foley Catheter received FDA 510(k) clearance on 2024-08-01, under 510(k) number K232469.

Who is the listed applicant for Rüsch Latex Gold Foley Catheter?

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 Rüsch Latex Gold Foley Catheter?

The FDA product code for Rüsch Latex Gold Foley Catheter 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。

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 K181852Percuvance经皮手术系统

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官方来源

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