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FDA 510(k)

重新处理过的PentaRay Nav eco高密度映射导管

K号: K201806 · 2021-06-23

申请人Sterilmed Inc. (Johnson and Johnson)
决定日期2021-06-23
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

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed Inc. (Johnson and Johnson). It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K201806. 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 Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Sterilmed Inc. (Johnson and Johnson). The 510(k) number is K201806.

When did Reprocessed PentaRay Nav eco High-Density Mapping Catheter receive FDA 510(k) clearance?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter received FDA 510(k) clearance on 2021-06-23, under 510(k) number K201806.

Who is the listed applicant for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA 510(k) record lists Sterilmed Inc. (Johnson and Johnson) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter 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。

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

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.K253205OptiMap 导管 - 50mm (OPTI-CATH2-50)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.

官方来源

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