FDA 510(k)

多恩爾馬格蘭輸尿管進入鞘

K 號：K201815 · 2020-11-20

決定日期2020-11-20

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

Dornier MAGELLAN Ureteral Access Sheath 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 2020-11-20 under 510(k) number K201815. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dornier MAGELLAN Ureteral Access Sheath?

Dornier MAGELLAN Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K201815.

When did Dornier MAGELLAN Ureteral Access Sheath receive FDA 510(k) clearance?

Dornier MAGELLAN Ureteral Access Sheath received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201815.

Who is the listed applicant for Dornier MAGELLAN Ureteral Access Sheath?

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 MAGELLAN Ureteral Access Sheath?

The FDA product code for Dornier MAGELLAN Ureteral Access Sheath is FED.

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

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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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