FDA 510(k)

再生处理Eagle Eye Platinum RX数字IVUS导管

K号: K210655 · 2022-05-25

决定日期2022-05-25

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

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K210655. 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 Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Innovative Health, LLC. The 510(k) number is K210655.

When did Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter receive FDA 510(k) clearance?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter received FDA 510(k) clearance on 2022-05-25, under 510(k) number K210655.

Who is the listed applicant for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

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

What is the FDA product code for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

The FDA product code for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is OWQ.

列明Innovative Health, 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。

K231015再处理超级扭矩和超级扭矩加诊断血管造影导管 K232037再处理VersaCross可弯曲鞘；再处理SureFlex可弯曲引导鞘 K230376再生处理Agilis NxT可弯曲引导器 K213584重新处理过的NRG经隔针 K221854再处理脐带电缆 K212165再生处理Carto Vizigo双向引导鞘

查看所有 48 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.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

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。