FDA 510(k)

TriSalus TriGuide™ 导丝引导导管

K号: K233858 · 2023-12-27

决定日期2023-12-27

产品代码DQY

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

TriSalus TriGuideTM Guiding Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Trisalus Life Sciences. It received FDA 510(k) clearance on 2023-12-27 under 510(k) number K233858. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TriSalus TriGuideTM Guiding Catheter?

TriSalus TriGuideTM Guiding Catheter is a medical device that received FDA 510(k) clearance on 2023-12-27. The listed applicant is Trisalus Life Sciences. The 510(k) number is K233858.

When did TriSalus TriGuideTM Guiding Catheter receive FDA 510(k) clearance?

TriSalus TriGuideTM Guiding Catheter received FDA 510(k) clearance on 2023-12-27, under 510(k) number K233858.

Who is the listed applicant for TriSalus TriGuideTM Guiding Catheter?

FDA 510(k)记录显示Trisalus Life Sciences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 TriSalus TriGuideTM Guiding Catheter?

The FDA product code for TriSalus TriGuideTM Guiding Catheter is DQY.

列明Trisalus Life Sciences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。

K253509TriSalus TriNav Advance 注射系统 K230957TriSalus TriNav® LV 静脉输液系统 K193107TriSalus输液系统

官方来源

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