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FDA 510(k)

VasoStat 止血設備

K 號:K153259 · 2016-01-06

決定日期2016-01-06
產品代碼DXC
諮詢委員會履歷
決定相當於

器材摘要

VasoStat Hemostasis Device is the device name listed in this FDA 510(k) record. The listed applicant is Forge Medical, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K153259. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VasoStat Hemostasis Device?

VasoStat Hemostasis Device is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Forge Medical, Inc.. The 510(k) number is K153259.

When did VasoStat Hemostasis Device receive FDA 510(k) clearance?

VasoStat Hemostasis Device received FDA 510(k) clearance on 2016-01-06, under 510(k) number K153259.

Who is the listed applicant for VasoStat Hemostasis Device?

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

What is the FDA product code for VasoStat Hemostasis Device?

The FDA product code for VasoStat Hemostasis Device is DXC.

相關臨床試驗

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相關器械(代碼:DXC)

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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