FDA 510(k)

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

K号: K241115 · 2024-11-27

决定日期2024-11-27

产品代码FOZ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K241115. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter?

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Spectrum Vascular. The 510(k) number is K241115.

When did SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter receive FDA 510(k) clearance?

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter received FDA 510(k) clearance on 2024-11-27, under 510(k) number K241115.

Who is the listed applicant for SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter?

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 SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter?

The FDA product code for SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter is FOZ.

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 K254278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

官方来源

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