pNOVUS 21 微导管
K号: K242420 · 2024-11-12
广告
申请人Phenox, Ltd.
决定日期2024-11-12
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：
---
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
pNOVUS 21 Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Phenox, Ltd.. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242420. 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 pNOVUS 21 Microcatheter?
pNOVUS 21 Microcatheter is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Phenox, Ltd.. The 510(k) number is K242420.
When did pNOVUS 21 Microcatheter receive FDA 510(k) clearance?
pNOVUS 21 Microcatheter received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242420.
Who is the listed applicant for pNOVUS 21 Microcatheter?
The FDA 510(k) record lists Phenox, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for pNOVUS 21 Microcatheter?
The FDA product code for pNOVUS 21 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Phenox, Ltd.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。
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, LLCK233268Impress 血管造影导管Merit Medical Systems, Inc.
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。
广告