FDA 510(k)

Steerant™ 超硬導絲

K 號：K232570 · 2023-10-24

決定日期2023-10-24

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Steerant™ Super Stiff Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232570. 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 Steerant™ Super Stiff Guidewire?

Steerant™ Super Stiff Guidewire is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Medtronic Vascular. The 510(k) number is K232570.

When did Steerant™ Super Stiff Guidewire receive FDA 510(k) clearance?

Steerant™ Super Stiff Guidewire received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232570.

Who is the listed applicant for Steerant™ Super Stiff Guidewire?

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

What is the FDA product code for Steerant™ Super Stiff Guidewire?

The FDA product code for Steerant™ Super Stiff Guidewire is DQX.

其他以 Medtronic Vascular 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。

K2321906F Sherpa NX Balanced Guide Catheter，7F Sherpa NX Balanced Guide Catheter K2301565F 启动导引导管，6F 启动导引导管，7F 启动导引导管，8F 启动导引导管 K220773埃佛勒斯20充氣設備及三通閥門（AC2200）；埃佛勒斯30充氣設備及三通閥門（AC3200）；埃佛勒斯20生存套件，內含：1. 埃佛勒斯20設備配三通閥門，2. 皮頓Y型接頭，3. 金屬導絲針插入針，4. 扭力把手（AC2205P）；埃佛勒斯30生存套件，內含：1. 埃佛勒斯30設備配三通閥門，2. 皮頓Y型接頭，3. 金屬導絲針插入針，4. 扭力把手（AC3205P）K192296美敦力6F泰加導管 K173515Admiral Xtreme K162097InTRAkit

查看所有 9 項裝置 →

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。