FDA 510(k)

Cleaner™ Pro 血栓切除术系统；Cleaner™ Pro 吸引导管带手柄；Cleaner™ Pro 吸引罐

K号: K232679 · 2024-01-19

决定日期2024-01-19

产品代码QEW

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™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro 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 2024-01-19 under 510(k) number K232679. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister?

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K232679.

When did Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister receive FDA 510(k) clearance?

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister received FDA 510(k) clearance on 2024-01-19, under 510(k) number K232679.

Who is the listed applicant for Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro 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™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister?

The FDA product code for Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister is QEW.

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）

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官方来源

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