FDA 510(k)

IMPEDE 栓塞器，5mm，IMPEDE 栓塞器，7mm，IMPEDE 栓塞器，10mm

K号: K181051 · 2018-06-22

决定日期2018-06-22

产品代码KRD

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

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is the device name listed in this FDA 510(k) record. The listed applicant is Shape Memory Medical. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K181051. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm?

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Shape Memory Medical. The 510(k) number is K181051.

When did IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm receive FDA 510(k) clearance?

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm received FDA 510(k) clearance on 2018-06-22, under 510(k) number K181051.

Who is the listed applicant for IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm?

The FDA 510(k) record lists Shape Memory Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm?

The FDA product code for IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is KRD.

列明Shape Memory Medical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。

K182390IMPEDE-FX 栓塞器

官方来源

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