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FDA 510(k)

Vein360 处理后视野 PV.014P 处方数字 IVUS 球囊导管，Vein360 处理后鹰眼铂金 Rx 数字 IVUS 球囊导管，Vein360 处理后鹰眼铂金 ST Rx 数字 IVUS 球囊导管

K号: K232584 · 2023-10-24

申请人Vein 360, LLC
决定日期2023-10-24
产品代码OWQ
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

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vein 360, LLC. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232584. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter?

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Vein 360, LLC. The 510(k) number is K232584.

When did Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter receive FDA 510(k) clearance?

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232584.

Who is the listed applicant for Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter?

The FDA 510(k) record lists Vein 360, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter?

The FDA product code for Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter is OWQ.

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Vein 360, LLC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。

K230928Vein360 处理后视野 PV.018 数字 IVUS 管腔内超声导管K230584Vein360 处理后视野 PV.035 数字 IVUS 导管K191073Vein360 静脉射频消融（RFA）导管

相关器械（代码：OWQ）

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。

K254149再生AcuNav CRYSTAL™超声导管9F x 90 CM，适用于西门子系统（R11510825）；再生AcuNav CRYSTAL™超声导管9F x 90 CM，适用于GE系统（R11657484）；再生SOUNDSTAR CRYSTAL™超声导管9F x 90 CM，适用于西门子系统（R11510826）；再生SOUNDSTAR CRYSTAL™超声导管9F x 90 CM，适用于GE系统（R11657485）Sterilmed, Inc.K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco 诊断超声导管（8F，8FG，10F，10FG）Surgical Instrument Service and Savings, Inc.K250592NES再处理Visions PV .018数字IVUS导管（R-86700）Northeast Scientific, Inc.K243101Medline ReNewal Reprocessed 西门子 ACUSON AcuNav 10F 超声波导管（适用于西门子系统）（08255790）；Medline ReNewal Reprocessed 西门子 ACUSON AcuNav 10F 超声波导管（适用于GE系统）（10043342）Surgical Instrument Service and Savings, Inc.K234064Medline ReNewal Reprocessed 西门子 ACUSON AcuNav 8F 超声波导管（适用于西门子系统）（10135936）；Medline ReNewal Reprocessed 西门子 ACUSON AcuNav 8F 超声波导管（适用于GE系统）（10135910）Surgical Instrument Service and Savings, Inc.K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE 导管Surgical Instrument Services and Savings, Inc.

官方来源

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