Kyphoplasty 气囊导管
K号: K223709 · 2023-08-16
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决定日期2023-08-16
产品代码HRX
咨询委员会OR
请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整：
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产品名称：[产品名称]
公司名称：[公司名称]
根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。
产品注册号：[注册号]
PMA编号：[PMA编号]
临床试验编号（NCT）：[NCT编号]
PubMed ID（PMID）：[PMID编号]
更多信息请访问以下链接：
[URL]
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请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同
器械摘要
Kyphoplasty Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Changmei Medtech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K223709. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Kyphoplasty Balloon Catheter?
Kyphoplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Jiangsu Changmei Medtech Co., Ltd.. The 510(k) number is K223709.
When did Kyphoplasty Balloon Catheter receive FDA 510(k) clearance?
Kyphoplasty Balloon Catheter received FDA 510(k) clearance on 2023-08-16, under 510(k) number K223709.
Who is the listed applicant for Kyphoplasty Balloon Catheter?
The FDA 510(k) record lists Jiangsu Changmei Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kyphoplasty Balloon Catheter?
The FDA product code for Kyphoplasty Balloon Catheter is HRX.
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。
相关器械（代码：HRX）
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。
K260203富勒椎体成形术球囊导管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯关节镜望远镜Karl Storz SE & CO. KGK252790数字ClarusScope系统及数字NeuroPEN系统Clarus Medical, LLCK253523Freedom DS®减压系统Spinal SimplicityK252546Vantage™ 腰椎减压套装Allevion Medical, LLCK253217MiiS Horus 眼镜镜片（EJA 100）；MiiS Horus 内窥镜显示系统 - 平板（EDS 500）；MiiS Horus 内窥镜显示系统 - 视频盒（EVS 700）Medimaging Integrated Solution, Inc (Miis)
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。
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