FDA 510(k)

魯士矽膠福萊氏導尿管

K 號：K161770 · 2017-05-05

決定日期2017-05-05

產品代碼EZL

諮詢委員會GU

決定相當於

器材摘要

Rusch Silicone 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 2017-05-05 under 510(k) number K161770. 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 Rusch Silicone Foley Catheter?

Rusch Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K161770.

When did Rusch Silicone Foley Catheter receive FDA 510(k) clearance?

Rusch Silicone Foley Catheter received FDA 510(k) clearance on 2017-05-05, under 510(k) number K161770.

Who is the listed applicant for Rusch Silicone 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 Rusch Silicone Foley Catheter?

The FDA product code for Rusch Silicone Foley Catheter 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。

K232469魯施天然乳膠金屬福樸導尿管 K212077泰勒弗萊克斯魯斯柔簡塑福利歐導尿管 K192324雪倫螺旋柔軟氣管內管 K182847Hudson RCI Voldyne體積訓練器 K181979魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管 K183461魯士Flocath親水性間歇性導尿管，魯士MMG親水性間歇性導尿管

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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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