FDA 510(k)

preCARDIA 阻塞系统

K号: K221294 · 2023-06-30

决定日期2023-06-30

产品代码MJN

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

preCARDIA Occlusion System is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K221294. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

What is the preCARDIA Occlusion System?

preCARDIA Occlusion System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Abiomed, Inc.. The 510(k) number is K221294.

When did preCARDIA Occlusion System receive FDA 510(k) clearance?

preCARDIA Occlusion System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K221294.

Who is the listed applicant for preCARDIA Occlusion System?

The FDA 510(k) record lists Abiomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for preCARDIA Occlusion System?

The FDA product code for preCARDIA Occlusion System is MJN.

列明Abiomed, Inc.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。

K25276614Fr 低轮廓引导器套装 K241708Abiomed 14Fr 低轮廓导引器套件 K223161OXY-1 系统 K222113Abiomed 14Fr 低轮廓导引器套装 K202330Impella XR 套管套装 K200109OXY-1 系统

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