FDA 510(k)

V•Stick™ 血管通路套装

K号: K253741 · 2025-12-15

决定日期2025-12-15

产品代码DYB

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

V•Stick™ Vascular Access Set is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K253741. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the V•Stick™ Vascular Access Set?

V•Stick™ Vascular Access Set is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K253741.

When did V•Stick™ Vascular Access Set receive FDA 510(k) clearance?

V•Stick™ Vascular Access Set received FDA 510(k) clearance on 2025-12-15, under 510(k) number K253741.

Who is the listed applicant for V•Stick™ Vascular Access Set?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V•Stick™ Vascular Access Set?

The FDA product code for V•Stick™ Vascular Access Set is DYB.

列明Argon Medical Devices, Inc.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。

K252795ZeniCore™ 自动活检仪器（863212100 / ZeniCore 自动活检设备 12ga x 10cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863212130 / ZeniCore 自动活检设备 12ga x 13cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863214100 / ZeniCore 自动活检设备 14ga x 10cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863214130 / ZeniCore 自动活检设备 14ga x 13cm 配同轴 K260028CLEANER® 真空血栓切除术系统，CLEANER® 真空吸引导管手柄，CLEANER® 真空吸引罐 K251318VariFuse 可调式输液导管 K242612Option ELITE 下腔静脉滤过系统 (352506070E 352506100E)K241145TLAB®经静脉肝活检系统（TF-18C）K233909Cleaner™ Plus 18F 血栓切除术系统 - Cleaner™ Plus 18F 吸引导管，Cleaner™ Plus 18F 手柄带浸软线，Cleaner™ Plus 18F 吸引罐

查看所有 18 个设备 →

相关器械（代码：DYB）

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。

K253526NAMIC 扩张器和套管Medline Industries, LP K261529微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（SIS05C）；微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（IS01）；引导器套件/微引导器套件/引导器套装/微引导器套装/微引导器鞘套装/引导器鞘套装（NIS04）Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line 可撕开引导器Health Line International Corporation K261492FieldFlex 可弯曲鞘CenterPoint Systems, LLC K260606Echo 大口径引导鞘Echo Medical, LLC

官方来源

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