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510(k) K254278

Arterial Pressure Monitoring Set/Tray by Spectrum Vascular — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2026
Date Received
December 30, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Spectrum Vascular

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  • K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; (November 27, 2024)

Other clearances for product code DQO

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  • K242420 — pNOVUS 21 Microcatheter (November 12, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
  • K232573 — INFINITI™ Ambi Angiographic Catheter (November 21, 2023)
  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)
  • K230411 — Dragonfly OpStar™ Imaging Catheter (April 14, 2023)