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FDA 510(k)

GlidePath 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

K号: K190527 · 2020-03-05

申请人C. R. Bard
决定日期2020-03-05
产品代码MSD
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定Unknown

器械摘要

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters 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 2020-03-05 under 510(k) number K190527. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is C. R. Bard. The 510(k) number is K190527.

When did GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters receive FDA 510(k) clearance?

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters received FDA 510(k) clearance on 2020-03-05, under 510(k) number K190527.

Who is the listed applicant for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

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 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

The FDA product code for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is MSD.

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。

K182281Site~Rite 8 超声系统带 Cue 尖端跟踪系统和 Pinpoint GT 尖端技术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：MSD）

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。

K241581血液透析导管Haolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro 长期血液透析导管C.R. Bard, Inc.K211410GlidePath 13F 长期血液透析导管Bard Peripheral Vascular, Inc.K203767Pristine 长期血液透析导管C B Bard, Inc.K202150GlidePath 7.5F 长期透析导管C.R. Bard, Inc.

官方来源

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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。

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