FDA 510(k)

袋鼠Avenir線圈系統

K 號：K173711 · 2018-05-04

決定日期2018-05-04

產品代碼HCG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Wallaby Avenir Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical, Inc.. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173711. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wallaby Avenir Coil System?

Wallaby Avenir Coil System is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Wallaby Medical, Inc.. The 510(k) number is K173711.

When did Wallaby Avenir Coil System receive FDA 510(k) clearance?

Wallaby Avenir Coil System received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173711.

Who is the listed applicant for Wallaby Avenir Coil System?

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

What is the FDA product code for Wallaby Avenir Coil System?

The FDA product code for Wallaby Avenir Coil System is HCG.

其他以 Wallaby Medical, Inc. 為申請人之記錄

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K2226036F Wallaby Long Sheath

相關器械（代碼：HCG）

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。

官方來源

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