FDA 510(k)

KardiFlex PTCA球囊扩张导管

K号: K202619 · 2021-04-29

决定日期2021-04-29

产品代码LOX

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

KardiFlex PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K202619. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KardiFlex PTCA Balloon Dilatation Catheter?

KardiFlex PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is Medcaptain Life Science Co., Ltd.. The 510(k) number is K202619.

When did KardiFlex PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

KardiFlex PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-04-29, under 510(k) number K202619.

Who is the listed applicant for KardiFlex PTCA Balloon Dilatation Catheter?

The FDA 510(k) record lists Medcaptain Life Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KardiFlex PTCA Balloon Dilatation Catheter?

The FDA product code for KardiFlex PTCA Balloon Dilatation Catheter is LOX.

列明Medcaptain Life Science 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。

K230528扩展套装 K213004无针连接器 K202578KardiFlex NC冠状动脉扩张导管 K202748肠内营养导管

官方来源

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