FDA 510(k)

Rocket铂金固化导管

K号: K210509 · 2021-09-09

决定日期2021-09-09

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Unknown

器械摘要

Rocket Platinum Cured Cathter 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 2021-09-09 under 510(k) number K210509. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

What is the Rocket Platinum Cured Cathter?

Rocket Platinum Cured Cathter is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Rocket Medical Plc. The 510(k) number is K210509.

When did Rocket Platinum Cured Cathter receive FDA 510(k) clearance?

Rocket Platinum Cured Cathter received FDA 510(k) clearance on 2021-09-09, under 510(k) number K210509.

Who is the listed applicant for Rocket Platinum Cured Cathter?

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 Platinum Cured Cathter?

The FDA product code for Rocket Platinum Cured Cathter 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。

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官方来源

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