FDA 510(k)

Acclarent NavWire 鼻窦導航導絲

K 號：K161697 · 2016-10-24

決定日期2016-10-24

產品代碼PGW

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

Acclarent NavWire Sinus Navigation Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161697. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Acclarent NavWire Sinus Navigation Guidewire?

Acclarent NavWire Sinus Navigation Guidewire is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Acclarent, Inc.. The 510(k) number is K161697.

When did Acclarent NavWire Sinus Navigation Guidewire receive FDA 510(k) clearance?

Acclarent NavWire Sinus Navigation Guidewire received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161697.

Who is the listed applicant for Acclarent NavWire Sinus Navigation Guidewire?

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

What is the FDA product code for Acclarent NavWire Sinus Navigation Guidewire?

The FDA product code for Acclarent NavWire Sinus Navigation Guidewire is PGW.

其他以 Acclarent, Inc. 為申請人之記錄

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相關器械（代碼：PGW）

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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