FDA 510(k)

Concerto Versa™ 可拆式線圈

K 號：K253511 · 2026-01-14

決定日期2026-01-14

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

Concerto Versa™ Detachable Coil is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-01-14 under 510(k) number K253511. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Concerto Versa™ Detachable Coil?

Concerto Versa™ Detachable Coil is a medical device that received FDA 510(k) clearance on 2026-01-14. The listed applicant is Medtronic, Inc.. The 510(k) number is K253511.

When did Concerto Versa™ Detachable Coil receive FDA 510(k) clearance?

Concerto Versa™ Detachable Coil received FDA 510(k) clearance on 2026-01-14, under 510(k) number K253511.

Who is the listed applicant for Concerto Versa™ Detachable Coil?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Concerto Versa™ Detachable Coil?

The FDA product code for Concerto Versa™ Detachable Coil is KRD.

其他以 Medtronic, Inc. 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。

K262913Protégé™ EverFlex™ 自擴張週邊支架系統 K262735LINQ II 可植入式心臟監護器 (ICM) (LNQ22)K262005Affera 整合地圖系統 K261335VitalFlow Set with Balance™ 生物表面 K261866Concerto Versa™ 可拆式線圈 K260195延長式單件動脈（EOPA）3D™ 運動脈管

查看所有 103 項裝置 →

相關器械（代碼：KRD）

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。

K252812UniPearls® 遮斷微膠球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可調適性栓塊Boston Scientific Corporation K261866Concerto Versa™ 可拆式線圈Medtronic, Inc.K260635HARBOR 閉塞設備Nuvascular, Inc.K260508LOBO血管栓塞系統Okami Medical, Inc.K253677坦博栓塞系統Instylla, Inc.

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。