MI DeTACH
K号: K210006 · 2021-03-04
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决定日期2021-03-04
产品代码DXC
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：
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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
MI DeTACH is the device name listed in this FDA 510(k) record. The listed applicant is Biorep Technologies, Inc.. It received FDA 510(k) clearance on 2021-03-04 under 510(k) number K210006. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MI DeTACH?
MI DeTACH is a medical device that received FDA 510(k) clearance on 2021-03-04. The listed applicant is Biorep Technologies, Inc.. The 510(k) number is K210006.
When did MI DeTACH receive FDA 510(k) clearance?
MI DeTACH received FDA 510(k) clearance on 2021-03-04, under 510(k) number K210006.
Who is the listed applicant for MI DeTACH?
The FDA 510(k) record lists Biorep Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MI DeTACH?
The FDA product code for MI DeTACH is DXC.
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：DXC）
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。
K262086PreludeSYNC™ 肘部压缩装置Merit Medical Systems, Inc.K260105Fogarty 弹簧夹，无手柄夹具和夹具插入物Edwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060救命止血带TW MedicalK243627喉镜接头动脉限制夹（L-ARC）；动脉限制夹（ARC）Arc Trauma, LLCK253070Namic径向臂带，23厘米（DYNJRADBAND）；Namic径向臂带，26厘米（DYNJRADBANDL）Medline Industries, LP
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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