FDA 510(k)

角形尖端輸尿管導管

K 號：K181144 · 2018-06-28

決定日期2018-06-28

產品代碼KOD

諮詢委員會GU

決定相當於

器材摘要

Angled Tip Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K181144. 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 Angled Tip Ureteral Catheter?

Angled Tip Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Cook Incorporated. The 510(k) number is K181144.

When did Angled Tip Ureteral Catheter receive FDA 510(k) clearance?

Angled Tip Ureteral Catheter received FDA 510(k) clearance on 2018-06-28, under 510(k) number K181144.

Who is the listed applicant for Angled Tip Ureteral Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Angled Tip Ureteral Catheter?

The FDA product code for Angled Tip Ureteral Catheter is KOD.

其他以 Cook Incorporated 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：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.K181979魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管Teleflexmedical, Inc.K180354UroGen 腎盂導尿管Urogen Pharma, Ltd.

官方來源

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