FDA 510(k)

FreedomFlow轨道环形动脉粥样硬化系统（H6004/5Fr 3球配置）

K号: K233483 · 2024-02-15

决定日期2024-02-15

产品代码MCW

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

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Flow Inc.,. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K233483. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)?

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Cardio Flow Inc.,. The 510(k) number is K233483.

When did FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) receive FDA 510(k) clearance?

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) received FDA 510(k) clearance on 2024-02-15, under 510(k) number K233483.

Who is the listed applicant for FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)?

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

What is the FDA product code for FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)?

The FDA product code for FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) is MCW.

列明Cardio Flow 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。

K250723FreedomFlow®轨道环形动脉粥样硬化系统（H6005/ 4Fr 3球配置）K242947FreedomFlow®轨道环形动脉粥样硬化系统 K231538FreedomFlow轨道环形动脉粥样硬化系统 K213834Cardio Flow外周导丝

官方来源

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