FDA 510(k)

APRO 55 中間腔管

K 號：K250962 · 2025-04-29

決定日期2025-04-29

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

APRO 55 Intermediate Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Alembic, LLC. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K250962. 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 APRO 55 Intermediate Catheter?

APRO 55 Intermediate Catheter is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Alembic, LLC. The 510(k) number is K250962.

When did APRO 55 Intermediate Catheter receive FDA 510(k) clearance?

APRO 55 Intermediate Catheter received FDA 510(k) clearance on 2025-04-29, under 510(k) number K250962.

Who is the listed applicant for APRO 55 Intermediate Catheter?

FDA 510(k) 記錄中將 Alembic, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for APRO 55 Intermediate Catheter?

The FDA product code for APRO 55 Intermediate Catheter is DQY.

其他以 Alembic, LLC 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。

K262391APRO 35 Swift 管腔內導管及Alembic 吸引管 K262392APRO 35 Swift 管針 K251014APRO 45 針管 K251015APRO 45 針管和 Alembic 吸引管 K250958APRO 55 Swift 腔管及阿勒姆吸管 K243287APRO 70 Swift 腔管及阿勒姆吸管

查看所有 12 項裝置 →

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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