FDA 510(k)

动脉压力监测套装/托盘

K号: K254278 · 2026-03-25

决定日期2026-03-25

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

Arterial Pressure Monitoring Set/Tray is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K254278. 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 Arterial Pressure Monitoring Set/Tray?

Arterial Pressure Monitoring Set/Tray is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Spectrum Vascular. The 510(k) number is K254278.

When did Arterial Pressure Monitoring Set/Tray receive FDA 510(k) clearance?

Arterial Pressure Monitoring Set/Tray received FDA 510(k) clearance on 2026-03-25, under 510(k) number K254278.

Who is the listed applicant for Arterial Pressure Monitoring Set/Tray?

FDA 510(k)记录将Spectrum Vascular列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Arterial Pressure Monitoring Set/Tray?

The FDA product code for Arterial Pressure Monitoring Set/Tray is DQO.

列明Spectrum Vascular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。

K260165未浸渍中心静脉导管 K261455动脉压力监测套装/托盘 K252373BioFlo 混合 PICC 配有 ENDEXO 技术和 PASV 阀技术；BioFlo PICC 配有 ENDEXO 技术和 PASV 阀技术；BioFlo PICC 配有 ENDEXO 技术；BioFlo 中线导管；Xcela 注射式 PICC；Xcela PICC 配有 PASV 阀技术；Xcela 混合 PICC 配有 PASV 阀技术 K250724骨内注射针 K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

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 Vascular K252702Bioptimal 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.K250751DualView导管Terumo Corporation K242966Gentuity® HF-OCT 成像系统，配备 Vis-Rx Prime® 微成像导管Gentuity, LLC K242420pNOVUS 21 微导管Phenox, Ltd.K233268Impress 血管造影导管Merit Medical Systems, Inc.

官方来源

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