FDA 510(k)

Firefighter™ Pro PTCA 气囊导管

K号: K252116 · 2026-04-07

申请人Shanghai MicroPort Medical (Group) Co., Ltd.

决定日期2026-04-07

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

Firefighter™ Pro PTCA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai MicroPort Medical (Group) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K252116. 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 Firefighter™ Pro PTCA Balloon Catheter?

Firefighter™ Pro PTCA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Shanghai MicroPort Medical (Group) Co., Ltd.. The 510(k) number is K252116.

When did Firefighter™ Pro PTCA Balloon Catheter receive FDA 510(k) clearance?

Firefighter™ Pro PTCA Balloon Catheter received FDA 510(k) clearance on 2026-04-07, under 510(k) number K252116.

Who is the listed applicant for Firefighter™ Pro PTCA Balloon Catheter?

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

What is the FDA product code for Firefighter™ Pro PTCA Balloon Catheter?

The FDA product code for Firefighter™ Pro PTCA Balloon Catheter is LOX.

列明Shanghai MicroPort Medical (Group) 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。

K223189Firefighter™ NC Pro PTCA 气囊导管

官方来源

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