FDA 510(k)

CrossTorq 14 导丝

K号: K193194 · 2019-12-13

决定日期2019-12-13

产品代码DQX

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

CrossTorq 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Cardio Access, LLC. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193194. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CrossTorq 14 Guidewire?

CrossTorq 14 Guidewire is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Scientia Cardio Access, LLC. The 510(k) number is K193194.

When did CrossTorq 14 Guidewire receive FDA 510(k) clearance?

CrossTorq 14 Guidewire received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193194.

Who is the listed applicant for CrossTorq 14 Guidewire?

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

What is the FDA product code for CrossTorq 14 Guidewire?

The FDA product code for CrossTorq 14 Guidewire is DQX.

官方来源

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CrossTorq 14 导丝

器械摘要

常见问题

相关临床试验

相关器械（代码：DQX）

官方来源