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FDA 510(k)

HAART 200 主动脉瓣成形装置 19mm，HAART 200 主动脉瓣成形装置 21mm，HAART 200 主动脉瓣成形装置 23mm，HAART 200 主动脉瓣成形装置 25mm

K号: K171431 · 2017-08-10

申请人Biostable Science & Engineering, Inc.
决定日期2017-08-10
产品代码PST
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

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm is the device name listed in this FDA 510(k) record. The listed applicant is Biostable Science & Engineering, Inc.. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K171431. The device is classified under product code PST. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm?

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Biostable Science & Engineering, Inc.. The 510(k) number is K171431.

When did HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm receive FDA 510(k) clearance?

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm received FDA 510(k) clearance on 2017-08-10, under 510(k) number K171431.

Who is the listed applicant for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm?

The FDA 510(k) record lists Biostable Science & Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm?

The FDA product code for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm is PST.

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Biostable Science & Engineering, Inc.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。

K163608HAART 300 主动脉瓣成形装置 19mm，HAART 300 主动脉瓣成形装置 21mm，HAART 300 主动脉瓣成形装置 23mm，HAART 300 主动脉瓣成形装置 25mm

相关器械（代码：PST）

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。

K163608HAART 300 主动脉瓣成形装置 19mm，HAART 300 主动脉瓣成形装置 21mm，HAART 300 主动脉瓣成形装置 23mm，HAART 300 主动脉瓣成形装置 25mmBiostable Science & Engineering, Inc.

官方来源

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