FDA 510(k)

Quantum 灌注双腔导管 31F-V1（DL31F-V1）

K号: K241248 · 2024-05-31

决定日期2024-05-31

产品代码DWF

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

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K241248. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241248.

When did Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) receive FDA 510(k) clearance?

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) received FDA 510(k) clearance on 2024-05-31, under 510(k) number K241248.

Who is the listed applicant for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

The FDA 510(k) record lists Spectrum Medical S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)?

The FDA product code for Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is DWF.

列明Spectrum Medical S.R.L.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。

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官方来源

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