FDA 510(k)

魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管

K 號：K181979 · 2019-05-24

決定日期2019-05-24

產品代碼KOD

諮詢委員會GU

決定相當於

器材摘要

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent 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 2019-05-24 under 510(k) number K181979. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K181979.

When did Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter receive FDA 510(k) clearance?

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter received FDA 510(k) clearance on 2019-05-24, under 510(k) number K181979.

Who is the listed applicant for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent 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 FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter?

The FDA product code for Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is KOD.

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 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 K181852Percuvance 皮膚穿刺外科系統

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相關器械（代碼：KOD）

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。

K251864橡膠多功能導尿管C.R. Bard, Inc.K220036Wellead 腎管導尿管Well Lead Medical Co., Ltd.K220730allFlex 腎管導管，Krait 腎管導管Allwin Medical Devices, Inc.K211032尿道導尿管 12 Fr，尿道導尿管 16 FrUrogen Pharma, Ltd.K180354UroGen 腎盂導尿管Urogen Pharma, Ltd.K181144角形尖端輸尿管導管Cook Incorporated

官方來源

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