FDA 510(k)

Zoom系统（Zoom 4S导管）

K号: K252046 · 2025-10-30

决定日期2025-10-30

产品代码NRY

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决定实质等同

器械摘要

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.

常见问题

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)记录将Imperative Care, Inc.列为申请人。这本身并不足以确立该设备制造商的身份。

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

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

列明Imperative Care, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261176Zoom 4S 导管 K252057Symphony™ 血栓切除术系统；Symphony™ 16F 82cm 血栓切除术系统 K244061X-Wire 导丝 K243047Zoom 7X 导管；Zoom 吸痰管；Zoom POD 吸痰管 K250775Symphony™ 血栓切除术系统；Symphony™ 16F 82cm 血栓切除术系统 K242672缩放系统

查看所有 18 个设备 →

官方来源

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