FDA 510(k)

SV Spectrum MRC中心靜脈針；SV Spectrum MR中心靜脈針；SV中心靜脈針

K 號：K241115 · 2024-11-27

決定日期2024-11-27

產品代碼FOZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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) 記錄將 Spectrum Vascular 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Spectrum Vascular 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260165未浸潤中心靜脈針管 K261455動脈壓力監測組/托盤 K254278動脈壓力監測組/托盤 K252373生物飛萊混合型PICC配備ENDEXO技術及PASV閥技術；生物飛萊PICC配備ENDEXO技術及PASV閥技術；生物飛萊PICC配備ENDEXO技術；生物飛萊中線針管；Xcela電漿注射型PICC；Xcela PICC配備PASV閥技術；Xcela混合型PICC配備PASV閥技術 K250724骨內輸液針

相關器械（代碼：FOZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260432Ruby 靜脈內導管Venocare, Inc.K260165未浸潤中心靜脈針管Spectrum Vascular K261041ClearSafe 關閉系統MedSource Labs, LLC K260539MedSource QuickSafe™ 安全靜脈針管；MedSource PurSafe™ 安全靜脈針管MedSource Labs, LLC K253235Introcan Safety® 深層進入XL IV 腔管B.Braun Medical, Inc.K252137BD Insyte® I.V. 穿刺針Becton Dickinson Infusion Therapy Systems, Inc.

官方來源

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