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FDA 510(k)

WIRION

K 號：K180023 · 2018-03-21

申請人Gardia Medical , Ltd.
決定日期2018-03-21
產品代碼NTE
諮詢委員會履歷
決定相當於

器材摘要

WIRION is the device name listed in this FDA 510(k) record. The listed applicant is Gardia Medical , Ltd.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K180023. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WIRION?

WIRION is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Gardia Medical , Ltd.. The 510(k) number is K180023.

When did WIRION receive FDA 510(k) clearance?

WIRION received FDA 510(k) clearance on 2018-03-21, under 510(k) number K180023.

Who is the listed applicant for WIRION?

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

What is the FDA product code for WIRION?

The FDA product code for WIRION is NTE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NTE）

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。

K222694EmPro EPS (EP4514C-190, EP6514C-190)；Nanoparasol EPS (PNP4514C-190, PNP6514C-190)MicroVention, Inc.K230402ENROUTE® 頸動脈神經保護系統Silk Road MedicalK220654ANGIOGUARD XP 過濾導絲, ANGIOGUARD RX 過濾導絲Cordis CorporationK210282WIRION 體內栓塊防護系統Cardiovascular Systems, Inc.K200198WIRIONCardiovascular Systems, Inc.K191173Emboshield NAV6 體內栓子防護系統，裸線過濾導線Abbott Vascular

官方來源

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