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FDA 510(k)

Medline 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）

K号: K243101 · 2025-03-10

申请人Surgical Instrument Service and Savings, Inc.
决定日期2025-03-10
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

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K243101. 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 Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)?

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K243101.

When did Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) received FDA 510(k) clearance on 2025-03-10, under 510(k) number K243101.

Who is the listed applicant for Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)?

The FDA product code for Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) 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Surgical Instrument Service and Savings, 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。

K250314Medline ReNewal 复加工 Abbott Agilis Nxt 导入器K252405Medline ReNewal Reprocessed Boston Scientific 动态尖端单向可调节诊断导管K250772Medline ReNewal Reprocessed Boston Scientific 动态 XT 单向可调节诊断导管K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco 诊断超声导管（8F，8FG，10F，10FG）K242225Medline ReNewal Reprocessed Abbott Inquiry 可调节诊断导管K241156Medline ReNewal Reprocessed 圣犹达医疗 Response 电生理导管，Supreme 电生理导管（401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401）

查看所有 23 个设备 →

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.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.K232584Vein360 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Vein 360, LLC

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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