FDA 510(k)

再处理脐带电缆

K号: K221854 · 2022-08-06

决定日期2022-08-06

产品代码NLH

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

Reprocesses Umbilical Cable 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 2022-08-06 under 510(k) number K221854. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocesses Umbilical Cable?

Reprocesses Umbilical Cable is a medical device that received FDA 510(k) clearance on 2022-08-06. The listed applicant is Innovative Health, LLC. The 510(k) number is K221854.

When did Reprocesses Umbilical Cable receive FDA 510(k) clearance?

Reprocesses Umbilical Cable received FDA 510(k) clearance on 2022-08-06, under 510(k) number K221854.

Who is the listed applicant for Reprocesses Umbilical Cable?

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 Reprocesses Umbilical Cable?

The FDA product code for Reprocesses Umbilical Cable is NLH.

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 K210655再生处理Eagle Eye Platinum RX数字IVUS导管 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：NLH）

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。

K252405Medline ReNewal Reprocessed Boston Scientific 动态尖端单向可调节诊断导管Surgical Instrument Service and Savings, Inc.K250772Medline ReNewal Reprocessed Boston Scientific 动态 XT 单向可调节诊断导管Surgical Instrument Service and Savings, Inc.K242225Medline ReNewal Reprocessed Abbott Inquiry 可调节诊断导管Surgical Instrument Service and Savings, Inc.K241224Medline ReNewal Reprocessed Biosense Webster Webster CS 导管带 EZ Steer 技术，以及 Medline ReNewal Reprocessed Biosense Webster Webster CS 导管带带 EZ Steer 技术和自动 ID 技术（BD710DF282CT，BD710DF282RTS，BD710FJ282RTS，BD710FJ282CT）Surgical Instrument Service and Savings Inc.(Dba Medline Ren K240826再生处理DECANAV™电生理导管；再生处理WEBSTER®双极电生理导管Sterilmed, Inc.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）Surgical Instrument Service 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。