FDA 510(k)

喉镜接头动脉限制夹（L-ARC）；动脉限制夹（ARC）

K号: K243627 · 2025-12-31

决定日期2025-12-31

产品代码DXC

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

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is the device name listed in this FDA 510(k) record. The listed applicant is Arc Trauma, LLC. It received FDA 510(k) clearance on 2025-12-31 under 510(k) number K243627. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Arc Trauma, LLC. The 510(k) number is K243627.

When did Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) receive FDA 510(k) clearance?

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) received FDA 510(k) clearance on 2025-12-31, under 510(k) number K243627.

Who is the listed applicant for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

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

What is the FDA product code for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)?

The FDA product code for Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) is DXC.

官方来源

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喉镜接头动脉限制夹（L-ARC）；动脉限制夹（ARC）

器械摘要

常见问题

相关临床试验

相关器械（代码：DXC）

官方来源