FDA 510(k)

魯士Flocath親水性間歇性導尿管，魯士MMG親水性間歇性導尿管

K 號：K183461 · 2019-05-08

決定日期2019-05-08

產品代碼GBM

諮詢委員會GU

決定Unknown

器材摘要

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG 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 2019-05-08 under 510(k) number K183461. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter?

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K183461.

When did Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter receive FDA 510(k) clearance?

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter received FDA 510(k) clearance on 2019-05-08, under 510(k) number K183461.

Who is the listed applicant for Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG 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 Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter?

The FDA product code for Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter is GBM.

其他以 Teleflexmedical, Inc. 為申請人之記錄

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相關器械（代碼：GBM）

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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