FDA 510(k)

Rocket IPC插入套件，Rocket IPC迷你插入套件

K号: K152105 · 2016-03-29

决定日期2016-03-29

产品代码PNG

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定Unknown

器械摘要

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2016-03-29 under 510(k) number K152105. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set?

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Rocket Medical Plc. The 510(k) number is K152105.

When did Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set receive FDA 510(k) clearance?

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set received FDA 510(k) clearance on 2016-03-29, under 510(k) number K152105.

Who is the listed applicant for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set?

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

What is the FDA product code for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set?

The FDA product code for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is PNG.

列明Rocket Medical Plc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。

K210509Rocket铂金固化导管 K163321Rocket留置胸腔导管（IPC）插入套件 K162457Rocket留置腹膜导管（IPC）插入套件

相关器械（代码：PNG）

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。

K241278ASEPT® Glide 腹膜引流系统Pfm Medical, Inc.K241946PeritX® 1L 引流包（90-1010）；PeritX® 2L 引流包（90-2010）；PeritX® 腹膜导管包（50-9000C）；PeritX® 腹膜导管和启动包（50-9900C）；PeritX® 腹膜导管迷你包（50-9050A）；PleurX® 低轮廓导管迷你包（50-8050）；阀门盖（50-7235A）；PeritX® 阀门包（50-7272）；导管通路包（50-7280A）；可锁定引流线（50-7245A）；可锁定引流线包（50-7265A）；PleurX® 补充插入包（50-7262）；手术包（50-）Bard Peripheral Vascular, Inc.K230319Passio 泵引流系统Bearpac Medical K221779ASEPT 腹膜引流系统Pfm Medical, Inc.K212675Aspira 腹膜透析引流系统Merit Medical Systems, Inc.K201155PleurX 腹膜导管系统Care Fusion

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。