FDA 510(k)

優質美克硝化鋼/金-鎳合金導引絲

K 號：K261640 · 2026-07-13

決定日期2026-07-13

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Merit MAK Nitinol/Gold-Tungsten Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Ireland , Ltd.. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K261640. 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 Merit MAK Nitinol/Gold-Tungsten Guide Wire?

Merit MAK Nitinol/Gold-Tungsten Guide Wire is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Merit Medical Ireland , Ltd.. The 510(k) number is K261640.

When did Merit MAK Nitinol/Gold-Tungsten Guide Wire receive FDA 510(k) clearance?

Merit MAK Nitinol/Gold-Tungsten Guide Wire received FDA 510(k) clearance on 2026-07-13, under 510(k) number K261640.

Who is the listed applicant for Merit MAK Nitinol/Gold-Tungsten Guide Wire?

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

What is the FDA product code for Merit MAK Nitinol/Gold-Tungsten Guide Wire?

The FDA product code for Merit MAK Nitinol/Gold-Tungsten Guide Wire is DQX.

其他以 Merit Medical Ireland , 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。

K254137InQwire Amplatz 引導絲 K253847Splashwire 水性導引絲 (MSWSTD35150J3)K251385InQwire超硬導引絲（IQSS32180J3）；InQwire超硬導引絲（IQSS35F260S）；InQwire超硬導引絲（IQSS35F150S）；InQwire超硬導引絲（IQSS35F100S）；InQwire超硬導引絲（IQSS35F80S）；InQwire超硬導引絲（IQSS35F180S）K251181Splashwire 水性導引絲 (MSWSTD35180J1O5)；Splashwire 水性導引絲 (MSWSTD35260J1O5)；Splashwire 水性導引絲 (MSWSTDA35150LT)；Splashwire 水性導引絲 (MSWSTFA35260LT)；Splashwire 水性導引絲 (MSWSTFA35150LT)；Splashwire 水性導引絲 (MSWSTFS38150LT)

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 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.K253746Enroute 0.014'' 頸動脈導絲Lake Region Medical

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