Plato MICROCATH 27B 微导管
K号: K170406 · 2017-04-18
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决定日期2017-04-18
产品代码DQO
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
Plato MICROCATH 27B Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K170406. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Plato MICROCATH 27B Microcatheter?
Plato MICROCATH 27B Microcatheter is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K170406.
When did Plato MICROCATH 27B Microcatheter receive FDA 510(k) clearance?
Plato MICROCATH 27B Microcatheter received FDA 510(k) clearance on 2017-04-18, under 510(k) number K170406.
Who is the listed applicant for Plato MICROCATH 27B Microcatheter?
The FDA 510(k) record lists Scientia Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Plato MICROCATH 27B Microcatheter?
The FDA product code for Plato MICROCATH 27B Microcatheter is DQO.
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Scientia Vascular, LLC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。
K220398Aristotle 14 导丝；Aristotle 18 导丝；Aristotle 24 导丝；Volo 14 导丝；Zoom Wire 14 导丝K210601Plato 17 微导管K201760Zoom 14 导丝K192783Aristotle 24 导丝，200cm，软型；Aristotle 24 导丝，200cm，标准型；Aristotle 24 导丝，200cm，支撑型K183608Aristotle 18 导丝，200cm，软型；Aristotle 18 导丝，200cm，标准型；Aristotle 18 导丝，200cm，支撑型K181828Volo 14 导丝，200cm，软型轮廓，Volo 14 导丝，200cm，标准轮廓，Volo 14 导丝，300cm，软型轮廓，Volo 14 导丝，300cm，标准轮廓
相关器械（代码：DQO）
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。
K261455动脉压力监测套装/托盘Spectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N)Bioptimal International Pte. , Ltd.K254278动脉压力监测套装/托盘Spectrum VascularK250751DualView导管Terumo CorporationK242966Gentuity® HF-OCT 成像系统，配备 Vis-Rx Prime® 微成像导管Gentuity, LLCK242420pNOVUS 21 微导管Phenox, Ltd.
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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