FDA 510(k)

泰勒弗萊克斯魯斯柔簡塑福利歐導尿管

K 號：K212077 · 2023-07-27

決定日期2023-07-27

產品代碼EZL

諮詢委員會GU

決定相當於

器材摘要

Teleflex Rusch SoftSimplastic 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 2023-07-27 under 510(k) number K212077. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Teleflex Rusch SoftSimplastic Foley Catheters?

Teleflex Rusch SoftSimplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K212077.

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

Teleflex Rusch SoftSimplastic Foley Catheters received FDA 510(k) clearance on 2023-07-27, under 510(k) number K212077.

Who is the listed applicant for Teleflex Rusch SoftSimplastic 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 Teleflex Rusch SoftSimplastic Foley Catheters?

The FDA product code for Teleflex Rusch SoftSimplastic Foley Catheters is EZL.

其他以 Teleflexmedical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EZL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260756TraumaGuard 腹腔內壓力感知系統 (000-0221)Sentinel Medical Technologies,K262056魯士拉特克斯金福樓伊姆導尿管Teleflex Medical Sdn. Bhd.K252537魯士軟簡塑福樸利氧導管Teleflex Medical Sdn. Bhd.K243011矽膠尿道導尿管（矽膠尿道導尿管）Guangdong Ecan Medical Co., Ltd.K241424InnoCare 專業福爾伊灌腸器Innocare Urologics, LLC K232469魯施天然乳膠金屬福樸導尿管Teleflexmedical, Inc.

官方來源

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