FDA 510(k)

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

K 號：K161912 · 2016-10-14

決定日期2016-10-14

產品代碼MOF

諮詢委員會CV

決定Substantially Equivalent

器材摘要

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161912. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161912.

When did ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip receive FDA 510(k) clearance?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161912.

Who is the listed applicant for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

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

What is the FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

The FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is MOF.

其他以 Asahi Intecc Co., 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。

K254178SAYA 86 Radial Access Guide Catheter K252011CHIKAI Nexus petit K251560FUBUKI XF-R Neurovascular Long Sheath K251240Branchor X Balloon Guide Catheter K243383CHIKAI Nexus 014 K243733SION blue PLUS

查看所有 45 項裝置 →

相關器械（代碼：MOF）

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。

K254181Aristotle 65 MacrowireScientia Vascular K26075135 Helix GuidewirePiraeus Medical, Inc.K262424Willow 12 GuidewireArbor Endovascular, LLC K260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。