FDA 510(k)

Zoom 系統（Zoom 4S 穿刺針）

K 號：K252046 · 2025-10-30

決定日期2025-10-30

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Zoom System (Zoom 4S Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252046. 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 Zoom System (Zoom 4S Catheter)?

Zoom System (Zoom 4S Catheter) is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Imperative Care, Inc.. The 510(k) number is K252046.

When did Zoom System (Zoom 4S Catheter) receive FDA 510(k) clearance?

Zoom System (Zoom 4S Catheter) received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252046.

Who is the listed applicant for Zoom System (Zoom 4S Catheter)?

FDA 510(k) 記錄將 Imperative Care, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Zoom System (Zoom 4S Catheter)?

The FDA product code for Zoom System (Zoom 4S Catheter) is NRY.

其他以 Imperative Care, 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。

K261176Zoom 4S 管針 K252057Symphony™ 靈栓切除系統及 Symphony™ 16F 82cm 靈栓切除系統 K244061X-Wire 導絲 K243047Zoom 7X 管子；Zoom 吸引管；Zoom POD 吸引管 K250775Symphony™ 靈栓切除系統；Symphony™ 16F 82cm 靈栓切除系統 K242672縮放系統

查看所有 18 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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