FDA 510(k)

Rocket留置胸腔导管（IPC）插入套件

K号: K163321 · 2017-08-17

决定日期2017-08-17

产品代码DWM

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit 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 2017-08-17 under 510(k) number K163321. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rocket Indwelling Pleural Catheter (IPC) Insertion Kit?

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Rocket Medical Plc. The 510(k) number is K163321.

When did Rocket Indwelling Pleural Catheter (IPC) Insertion Kit receive FDA 510(k) clearance?

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit received FDA 510(k) clearance on 2017-08-17, under 510(k) number K163321.

Who is the listed applicant for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit?

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 Indwelling Pleural Catheter (IPC) Insertion Kit?

The FDA product code for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is DWM.

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 K162457Rocket留置腹膜导管（IPC）插入套件 K152105Rocket IPC插入套件，Rocket IPC迷你插入套件

官方来源

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