FDA 510(k)

LOBO 血管闭塞系统

K号: K260508 · 2026-04-10

决定日期2026-04-10

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

LOBO Vascular Occlusion System is the device name listed in this FDA 510(k) record. The listed applicant is Okami Medical, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260508. 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 LOBO Vascular Occlusion System?

LOBO Vascular Occlusion System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Okami Medical, Inc.. The 510(k) number is K260508.

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

LOBO Vascular Occlusion System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260508.

Who is the listed applicant for LOBO Vascular Occlusion System?

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

What is the FDA product code for LOBO Vascular Occlusion System?

The FDA product code for LOBO Vascular Occlusion System is KRD.

列明Okami Medical, 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。

K242644SENDERO MAX 递送导管 K240384SENDERO 微导管 K231600SENDERO 微导管

官方来源

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