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FDA 510(k)

Cleaner Plus™ 血栓切除术系统，Cleaner Plus™ 吸引导管，Cleaner Plus™ 手柄带 65cm 浸软线，Cleaner Plus™ 手柄带 135cm 浸软线，Cleaner Plus™ 吸引罐

K号: K223176 · 2023-04-10

申请人Argon Medical Devices, Inc.
决定日期2023-04-10
产品代码KRA
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

Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister 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 2023-04-10 under 510(k) number K223176. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister?

Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister is a medical device that received FDA 510(k) clearance on 2023-04-10. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K223176.

When did Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister receive FDA 510(k) clearance?

Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister received FDA 510(k) clearance on 2023-04-10, under 510(k) number K223176.

Who is the listed applicant for Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister?

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 Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister?

The FDA product code for Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister is KRA.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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K253741V•Stick™ 血管通路套装K242612Option ELITE 下腔静脉滤过系统 (352506070E 352506100E)K241145TLAB®经静脉肝活检系统（TF-18C）

查看所有 18 个设备 →

相关器械（代码：KRA）

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Trisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ 微导管Instylla, Inc.K260771TruSelect™ 2.6 微导管Boston Scientific CorporationK250794InVera 注射器Invera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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