FDA 510(k)

V-DAC 导管

K号: K251097 · 2026-01-06

决定日期2026-01-06

产品代码QJP

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

V-DAC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K251097. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the V-DAC Catheter?

V-DAC Catheter is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Vesalio, Inc.. The 510(k) number is K251097.

When did V-DAC Catheter receive FDA 510(k) clearance?

V-DAC Catheter received FDA 510(k) clearance on 2026-01-06, under 510(k) number K251097.

Who is the listed applicant for V-DAC Catheter?

FDA 510(k)记录中列出Vesalio, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for V-DAC Catheter?

The FDA product code for V-DAC Catheter is QJP.

列明Vesalio, 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。

K254211pVasc Net 机械血栓切除术设备 K253407NeVa PV 血栓切除术装置 K251006NeVasc 吸引系统 K251312维斯阿利奥外周系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。