免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Vycor Medical 视频脑部接入系统（“VBAS”）及配备对齐夹的 VBAS（统称为“VBAS 系列产品”）

K号: K202694 · 2021-01-14

申请人Vycor Medical, Inc.
决定日期2021-01-14
产品代码GZT
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is the device name listed in this FDA 510(k) record. The listed applicant is Vycor Medical, Inc.. It received FDA 510(k) clearance on 2021-01-14 under 510(k) number K202694. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is a medical device that received FDA 510(k) clearance on 2021-01-14. The listed applicant is Vycor Medical, Inc.. The 510(k) number is K202694.

When did Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) receive FDA 510(k) clearance?

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) received FDA 510(k) clearance on 2021-01-14, under 510(k) number K202694.

Who is the listed applicant for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

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

What is the FDA product code for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)?

The FDA product code for Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) is GZT.

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：GZT）

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。

K252995杜拉盾设备套件SurGenTec, LLCK210615汤普森脑拉钩桌式（TM），汤普森脑拉钩颅骨夹式（SCM）Thompson Surgical Instruments, Inc.K202072MindsEye 可扩展端口Minnetronix Neuro, Inc.K180610Geister神经和脊柱手术拉钩Geister Medizin Technik GmbHK172433NICO BrainPathNico CorporationK161680MEDICON脊柱扩张系统Medicon EG

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。

↑