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FDA 510(k)

InQwire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）

K 號：K251385 · 2026-01-21

申請人Merit Medical Ireland, Ltd.
決定日期2026-01-21
產品代碼DQX
諮詢委員會履歷
決定相當於

器材摘要

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) 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 2026-01-21 under 510(k) number K251385. 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 InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)?

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Merit Medical Ireland, Ltd.. The 510(k) number is K251385.

When did InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) receive FDA 510(k) clearance?

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) received FDA 510(k) clearance on 2026-01-21, under 510(k) number K251385.

Who is the listed applicant for InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)?

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 InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)?

The FDA product code for InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) is DQX.

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

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。

K261640優質美克硝化鋼/金-鎳合金導引絲K254137InQwire Amplatz 引導絲K253847Splashwire 水性導引絲 (MSWSTD35150J3)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/SK261640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

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