FDA 510(k)

双通道双入口导管

K号: K193119 · 2020-06-29

决定日期2020-06-29

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

Twin-Pass Dual Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2020-06-29 under 510(k) number K193119. 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 Twin-Pass Dual Access Catheter?

Twin-Pass Dual Access Catheter is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K193119.

When did Twin-Pass Dual Access Catheter receive FDA 510(k) clearance?

Twin-Pass Dual Access Catheter received FDA 510(k) clearance on 2020-06-29, under 510(k) number K193119.

Who is the listed applicant for Twin-Pass Dual Access Catheter?

The FDA 510(k) record lists Vascular Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Twin-Pass Dual Access Catheter?

The FDA product code for Twin-Pass Dual Access Catheter is DQY.

列明Vascular Solutions, LLC为申报人的其他记录

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