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FDA 510(k)

Symetrex LTHD 导管，Symetrex LTHD 导管带侧孔

K号: K202176 · 2020-09-03

申请人Medical Components, Inc. (dba MedComp)
决定日期2020-09-03
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。
决定实质等同

器械摘要

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202176. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K202176.

When did Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes receive FDA 510(k) clearance?

Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202176.

Who is the listed applicant for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA 510(k) record lists Medical Components, Inc. (dba MedComp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes?

The FDA product code for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes 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Medical Components, Inc. (dba MedComp)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。

K232945Trio-CT® 三腔导管带弯曲延长件K192807Duo-Flow 侧侧双腔导管K183219三联CT三腔导管K18117512F 三通流三腔导管K17366715.5F X 19 cm Symetrex 长期血液透析导管带侧孔，15.5F X 23 cm Symetrex 长期血液透析导管带侧孔，15.5F X 28 cm Symetrex 长期血液透析导管带侧孔，15.5F X 33 cm Symetrex 长期血液透析导管带侧孔，15.5F X 37 cm Symetrex 长期血液透析导管带侧孔K180567C3 波系统

查看所有 9 个设备 →

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

在 FDA 数据库中查看 →

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