FDA 510(k)

動脈壓力監測組/托盤

K 號：K254278 · 2026-03-25

決定日期2026-03-25

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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) 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 Arterial Pressure Monitoring Set/Tray?

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

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 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 K241115SV Spectrum MRC中心靜脈針；SV Spectrum MR中心靜脈針；SV中心靜脈針

相關器械（代碼：DQO）

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。

K261455動脈壓力監測組/托盤Spectrum Vascular K252702生物優質肺動脈監測導管（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.K250751雙視窗導管Terumo Corporation K242966Gentuity® 高頻率OCT影像系統搭配Vis-Rx Prime® 微影像導管Gentuity, LLC K242420pNOVUS 21 微导管Phenox, Ltd.K233268印象血管內視鏡針管Merit Medical Systems, Inc.

官方來源

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