FDA 510(k)

Micro Catheter 和导丝系统

K号: K212719 · 2022-04-11

申请人Suzhou Hengrui Hongyuan Medical Co., Ltd.

决定日期2022-04-11

产品代码KRA

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

Micro Catheter and Guidewire System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K212719. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Micro Catheter and Guidewire System?

Micro Catheter and Guidewire System is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K212719.

When did Micro Catheter and Guidewire System receive FDA 510(k) clearance?

Micro Catheter and Guidewire System received FDA 510(k) clearance on 2022-04-11, under 510(k) number K212719.

Who is the listed applicant for Micro Catheter and Guidewire System?

The FDA 510(k) record lists Suzhou Hengrui Hongyuan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro Catheter and Guidewire System?

The FDA product code for Micro Catheter and Guidewire System is KRA.

列明Suzhou Hengrui Hongyuan Medical Co., Ltd.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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