FDA 510(k)

NeVa PV 血栓切除术装置

K号: K253407 · 2025-11-24

决定日期2025-11-24

产品代码QEX

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

NeVa PV Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K253407. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

What is the NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Vesalio, Inc.. The 510(k) number is K253407.

When did NeVa PV Thrombectomy Device receive FDA 510(k) clearance?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2025-11-24, under 510(k) number K253407.

Who is the listed applicant for NeVa PV Thrombectomy Device?

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 NeVa PV Thrombectomy Device?

The FDA product code for NeVa PV Thrombectomy Device is QEX.

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 K251097V-DAC 导管 K251006NeVasc 吸引系统 K251312维斯阿利奥外周系统

官方来源

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