FDA 510(k)再处理的Inquiry可操纵诊断电生理导管
K号: K160496 · 2016-06-10
决定日期2016-06-10
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
Reprocessed Inquiry Steerable Diagnostic EP 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 2016-06-10 under 510(k) number K160496. 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 Reprocessed Inquiry Steerable Diagnostic EP Catheter?
Reprocessed Inquiry Steerable Diagnostic EP Catheter is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Innovative Health, LLC. The 510(k) number is K160496.
When did Reprocessed Inquiry Steerable Diagnostic EP Catheter receive FDA 510(k) clearance?
Reprocessed Inquiry Steerable Diagnostic EP Catheter received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160496.
Who is the listed applicant for Reprocessed Inquiry Steerable Diagnostic EP 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 Inquiry Steerable Diagnostic EP Catheter?
The FDA product code for Reprocessed Inquiry Steerable Diagnostic EP Catheter is NLH.
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。
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。
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 RenK240826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.