FDA 510(k)

Amplatzer TorqVue 遞送系統

K 號：K260993 · 2026-04-24

申請人Abbott

決定日期2026-04-24

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Amplatzer TorqVue Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260993. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Amplatzer TorqVue Delivery System?

Amplatzer TorqVue Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Abbott. The 510(k) number is K260993.

When did Amplatzer TorqVue Delivery System receive FDA 510(k) clearance?

Amplatzer TorqVue Delivery System received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260993.

Who is the listed applicant for Amplatzer TorqVue Delivery System?

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

What is the FDA product code for Amplatzer TorqVue Delivery System?

The FDA product code for Amplatzer TorqVue Delivery System is DQY.

其他以 Abbott 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。

K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管 K251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)K233655醫療設備名稱：Lingo血糖系統 K222297CentriMag 預連接包 K221213EnSite X EP 系統 K212061EnSite X EP 系統

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相關器械（代碼：DQY）

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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLC K262240SSPC NXT 輸送導管CenterPoint Systems, LLC K261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLC K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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