FDA 510(k)

ENROUTE 0.014 導絲管

K 號：K160643 · 2016-10-18

決定日期2016-10-18

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

ENROUTE 0.014 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K160643. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ENROUTE 0.014 Guidewire?

ENROUTE 0.014 Guidewire is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Lake Region Medical. The 510(k) number is K160643.

When did ENROUTE 0.014 Guidewire receive FDA 510(k) clearance?

ENROUTE 0.014 Guidewire received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160643.

Who is the listed applicant for ENROUTE 0.014 Guidewire?

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

What is the FDA product code for ENROUTE 0.014 Guidewire?

The FDA product code for ENROUTE 0.014 Guidewire is DQX.

其他以 Lake Region Medical 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。

K253746Enroute 0.014'' 頸動脈導絲 K242824聚四氟乙烯導絲 K221575預成型藍色 K211741預成型額外支撐導絲

相關器械（代碼：DQX）

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。

K253146超驅35導絲Rapid-Medical , Ltd.K261281CROSSLEAD 标準 035 和 CROSSLEAD 硬度 035Filmecc Co., Ltd.K253667Accoat 引導絲Sp Medical A/S K261640優質美克硝化鋼/金-鎳合金導引絲Merit Medical Ireland , Ltd.K254137InQwire Amplatz 引導絲Merit Medical Ireland, Ltd.K260544FMD周邊導引絲F-14柔軟6；FMD周邊導引絲F-14緩坡40；FMD周邊導引絲F-18柔軟SP；FMD周邊導引絲F-18 DP 25；FMD周邊導引絲F-18緩坡40FMD Co., Ltd.

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。