FDA 510(k)

獨步節奏融合系統（SOLOFUSE1）

K 號：K252674 · 2026-01-09

決定日期2026-01-09

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Solo Pace Fusion System (SOLOFUSE1) is the device name listed in this FDA 510(k) record. The listed applicant is Solo Pace, Inc.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K252674. 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 Solo Pace Fusion System (SOLOFUSE1)?

Solo Pace Fusion System (SOLOFUSE1) is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Solo Pace, Inc.. The 510(k) number is K252674.

When did Solo Pace Fusion System (SOLOFUSE1) receive FDA 510(k) clearance?

Solo Pace Fusion System (SOLOFUSE1) received FDA 510(k) clearance on 2026-01-09, under 510(k) number K252674.

Who is the listed applicant for Solo Pace Fusion System (SOLOFUSE1)?

The FDA 510(k) record lists Solo Pace, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solo Pace Fusion System (SOLOFUSE1)?

The FDA product code for Solo Pace Fusion System (SOLOFUSE1) is DQX.

其他以 Solo Pace, Inc. 為申請人之記錄

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K241781單獨節拍控制

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

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