OptiMap 导管 - 50mm (OPTI-CATH2-50)
K号: K253205 · 2026-03-13
广告
申请人Cortex, Inc.
决定日期2026-03-13
产品代码MTD
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
OptiMap Catheter - 50mm (OPTI-CATH2-50) is the device name listed in this FDA 510(k) record. The listed applicant is Cortex, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K253205. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OptiMap Catheter - 50mm (OPTI-CATH2-50)?
OptiMap Catheter - 50mm (OPTI-CATH2-50) is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Cortex, Inc.. The 510(k) number is K253205.
When did OptiMap Catheter - 50mm (OPTI-CATH2-50) receive FDA 510(k) clearance?
OptiMap Catheter - 50mm (OPTI-CATH2-50) received FDA 510(k) clearance on 2026-03-13, under 510(k) number K253205.
Who is the listed applicant for OptiMap Catheter - 50mm (OPTI-CATH2-50)?
The FDA 510(k) record lists Cortex, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OptiMap Catheter - 50mm (OPTI-CATH2-50)?
The FDA product code for OptiMap Catheter - 50mm (OPTI-CATH2-50) is MTD.
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Cortex, 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。
相关器械（代码：MTD）
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。
K261012OptiMap 导管 - 60mm (OPTI-CATH2-60)Cortex, Inc.K233433Sphere-9Dx 诊断导管 (AFR-00009)MedtronicK241372Advisor™ HD网格X映射导管，传感器启用™ABBOTT MEDICALK231312PENTARAY® NAV ECO高密度测绘导管，DECANAV®测绘导管，Webster® CS导管带自动ID，Webster® CS导管带EZ Steer技术，Webster® CS导管带EZ Steer技术与自动IDBiosense Webster, Inc.K223666Ablacath™ 映射导管Ablacon, Inc.K230253OPTRELL™ Mapping 导管 TRUEref™ 技术Biosense Webster, 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。
广告