FDA 510(k)

WIRION

K 號：K200198 · 2020-03-18

決定日期2020-03-18

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 Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2020-03-18 under 510(k) number K200198. 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 2020-03-18. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K200198.

When did WIRION receive FDA 510(k) clearance?

WIRION received FDA 510(k) clearance on 2020-03-18, under 510(k) number K200198.

Who is the listed applicant for WIRION?

The FDA 510(k) record lists Cardiovascular Systems, Inc. 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.

其他以 Cardiovascular Systems, Inc. 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。

K220109DIAMONDBACK 360周邊 orbital動脈粥樣硬化切除系統，DIAMONDBACK 360周邊 orbital動脈粥樣硬化切除系統，可交換系列，Stealth 360周邊 orbital動脈粥樣硬化切除系統 K212725ViperCross 支援導管 K210586Diamonback 360 周邊 orbital 腦中風切除系統，Diamondback 360 Stealth orbital 腦中風切除系統 K211240ViperCross 支援導管 K211251ViperCath XC 頸外周交換導管 K210282WIRION 體內栓塊防護系統

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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 Medical K220654ANGIOGUARD XP 過濾導絲, ANGIOGUARD RX 過濾導絲Cordis Corporation K210282WIRION 體內栓塊防護系統Cardiovascular Systems, Inc.K191173Emboshield NAV6 體內栓子防護系統，裸線過濾導線Abbott Vascular K180023WIRIONGardia Medical , Ltd.

官方來源

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