FDA 510(k)

多尼爾 MINNOW 腎管導管

K 號：K191187 · 2019-09-18

決定日期2019-09-18

產品代碼EYB

諮詢委員會GU

決定相當於

器材摘要

Dornier MINNOW Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K191187. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dornier MINNOW Ureteral Catheter?

Dornier MINNOW Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K191187.

When did Dornier MINNOW Ureteral Catheter receive FDA 510(k) clearance?

Dornier MINNOW Ureteral Catheter received FDA 510(k) clearance on 2019-09-18, under 510(k) number K191187.

Who is the listed applicant for Dornier MINNOW Ureteral Catheter?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dornier MINNOW Ureteral Catheter?

The FDA product code for Dornier MINNOW Ureteral Catheter is EYB.

其他以 Dornier Medtech America, Inc. 為申請人之記錄

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相關器械（代碼：EYB）

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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