FDA 510(k)

血管擴張器

K 號：K163524 · 2017-06-29

決定日期2017-06-29

產品代碼DWP

諮詢委員會履歷

決定相當於

器材摘要

Vessel Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Fetzer Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K163524. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vessel Dilator?

Vessel Dilator is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Fetzer Medical GmbH & Co. KG. The 510(k) number is K163524.

When did Vessel Dilator receive FDA 510(k) clearance?

Vessel Dilator received FDA 510(k) clearance on 2017-06-29, under 510(k) number K163524.

Who is the listed applicant for Vessel Dilator?

The FDA 510(k) record lists Fetzer Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vessel Dilator?

The FDA product code for Vessel Dilator is DWP.

其他以 Fetzer Medical GmbH & Co. KG 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。

K172661Fetzer醫療婦科鉗子 K161004自保持拉開器

相關器械（代碼：DWP）

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。

K220981SUPERPLAST雙封閉器，SUPERPLAST血管探針Fehling Surgical Instruments, Inc.K183438Geomed 頸動脈擴張器Geomed Medizin-Technik GmbH & Co.

官方來源

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