Benchmark BMX96 访问系统
K号: K213390 · 2022-08-18
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决定日期2022-08-18
产品代码QJP
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]
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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
Benchmark BMX96 Access System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K213390. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Benchmark BMX96 Access System?
Benchmark BMX96 Access System is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is Penumbra, Inc.. The 510(k) number is K213390.
When did Benchmark BMX96 Access System receive FDA 510(k) clearance?
Benchmark BMX96 Access System received FDA 510(k) clearance on 2022-08-18, under 510(k) number K213390.
Who is the listed applicant for Benchmark BMX96 Access System?
The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Benchmark BMX96 Access System?
The FDA product code for Benchmark BMX96 Access System is QJP.
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。
列明Penumbra, 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。
K250690Penumbra 系统（Thunderbolt 吸引导管）K260599INDIGO® Aspiration System – INDIGO LinkK251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKK252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingK250079Ruby XL 系统K242104Penumbra 系统（再灌注导管 RED 72）
相关器械（代码：QJP）
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。
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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