Lunderquist 额外硬质导丝
K号: K171513 · 2017-12-07
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决定日期2017-12-07
产品代码DQX
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
Lunderquist Extra Stiff Wire Guide is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K171513. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lunderquist Extra Stiff Wire Guide?
Lunderquist Extra Stiff Wire Guide is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is William Cook Europe Aps. The 510(k) number is K171513.
When did Lunderquist Extra Stiff Wire Guide receive FDA 510(k) clearance?
Lunderquist Extra Stiff Wire Guide received FDA 510(k) clearance on 2017-12-07, under 510(k) number K171513.
Who is the listed applicant for Lunderquist Extra Stiff Wire Guide?
The FDA 510(k) record lists William Cook Europe Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lunderquist Extra Stiff Wire Guide?
The FDA product code for Lunderquist Extra Stiff Wire Guide is DQX.
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William Cook Europe Aps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。
K251596Lunderquist 额外硬质导丝K251499Frova插管引导器（C-CAE-14.0-70-FII）；Frova插管引导器（C-CAE-14.0-70-FI）；Frova插管引导器（C-CAE-14.0-70-FIC）；Frova插管引导器（C-CAE-14.0-70-FIC-SPOPS）K233680Celect Platinum 股静脉滤器套装 (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum 颈静脉滤器套装 (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum 股静脉和颈静脉滤器套装 (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip 股静脉滤器套装 (IGTCFS-65-1-FEM-TULIP); Günther Tulip 颈静脉滤器套装 (IGTCFS-65-1-JUG-TULIP); Günther Tulip 静脉滤器K220137Lunderquist 额外硬质导丝K211875Cook Celect Platinum 股静脉途径下腔静脉滤器套装，Cook Celect Platinum 颈静脉途径下腔静脉滤器套装，Cook Celect Platinum 股静脉和颈静脉途径下腔静脉滤器套装K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
相关器械（代码：DQX）
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。
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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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