FDA 510(k)

守護者下腔靜脈篩

K 號：K162875 · 2017-02-17

決定日期2017-02-17

產品代碼DTK

諮詢委員會履歷

決定相當於

器材摘要

Sentry IVC filter is the device name listed in this FDA 510(k) record. The listed applicant is Novate Medical , Ltd.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K162875. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sentry IVC filter?

Sentry IVC filter is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Novate Medical , Ltd.. The 510(k) number is K162875.

When did Sentry IVC filter receive FDA 510(k) clearance?

Sentry IVC filter received FDA 510(k) clearance on 2017-02-17, under 510(k) number K162875.

Who is the listed applicant for Sentry IVC filter?

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

What is the FDA product code for Sentry IVC filter?

The FDA product code for Sentry IVC filter is DTK.

其他以 Novate Medical , Ltd. 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。

K181202守護者下腔靜脈篩網 K173236守護者下腔靜脈篩網

相關器械（代碼：DTK）

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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