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FDA 510(k)

Site~Rite 8 超声系统带 Cue 尖端跟踪系统和 Pinpoint GT 尖端技术

K号: K182281 · 2018-10-24

申请人C. R. Bard
决定日期2018-10-24
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K182281. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is C. R. Bard. The 510(k) number is K182281.

When did Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech receive FDA 510(k) clearance?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech received FDA 510(k) clearance on 2018-10-24, under 510(k) number K182281.

Who is the listed applicant for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

The FDA 510(k) record lists C. R. Bard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

The FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is IYO.

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

列明C. R. Bard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。

K190527GlidePath 长期血液透析导管，HemoStar 长期血液透析导管，HemoStar XK 长期血液透析导管K172571ULTRASCORE聚焦力量PTA球囊K170294VENTRALIGHT ST 网格配合 ECHO 2 定位系统 11cm（4.5英寸）圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 10cm x 15cm（4英寸x 6英寸）椭圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 15cm（6英寸）圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 15cm x 20cm（6英寸x8英寸）椭圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 15cm x 25cm（6英寸x10英寸）椭圆形K162193XenMatrix AB 外科移植物

相关器械（代码：IYO）

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。

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官方来源

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