FDA 510(k)

Selethru PTCA 球囊扩张导尿管

K号: K182699 · 2018-11-26

决定日期2018-11-26

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

Selethru PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K182699. 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 Selethru PTCA Balloon Dilatation Catheter?

Selethru PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. The 510(k) number is K182699.

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

Selethru PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-11-26, under 510(k) number K182699.

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

FDA 510(k)记录将科塞尔医疗科技（苏州）有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

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

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

列明Kossel Medtech (Suzhou) 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。

K254212NC PTA球囊扩张导管 K231402HP PTA 气囊扩张导管 K221245PTA 气球扩张导管 K211349Selebrek PTCA 球囊扩张导管 K211393Selethru(TM) NC PTCA 球囊扩张导尿管

官方来源

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