FDA 510(k)

APRO 55 Swift 腔管及阿勒姆吸管

K 號：K250958 · 2025-04-28

決定日期2025-04-28

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

APRO 55 Swift Catheter and Alembic Aspiration Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Alembic, LLC. It received FDA 510(k) clearance on 2025-04-28 under 510(k) number K250958. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the APRO 55 Swift Catheter and Alembic Aspiration Tubing?

APRO 55 Swift Catheter and Alembic Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2025-04-28. The listed applicant is Alembic, LLC. The 510(k) number is K250958.

When did APRO 55 Swift Catheter and Alembic Aspiration Tubing receive FDA 510(k) clearance?

APRO 55 Swift Catheter and Alembic Aspiration Tubing received FDA 510(k) clearance on 2025-04-28, under 510(k) number K250958.

Who is the listed applicant for APRO 55 Swift Catheter and Alembic Aspiration Tubing?

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 Swift Catheter and Alembic Aspiration Tubing?

The FDA product code for APRO 55 Swift Catheter and Alembic Aspiration Tubing is NRY.

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 K250962APRO 55 中間腔管 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：NRY）

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。

K261089極端064再灌流導管；極端076再灌流導管；極端吸引管套組Maduro Medical, Inc.K260617虎獵者13超級再血管化設備Rapid Medical Ltd.K262398CEREGLIDE 57 中間導管；Cerenovus 吸引管組CERENOVUS, Inc.K262399蜈蚣系統Perfuze, Ltd.K262391APRO 35 Swift 管腔內導管及Alembic 吸引管Alembic, LLC K260002索福克勒斯吸引系統（索福克勒斯70吸引針）Scientia Vascular, Inc.

官方來源

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