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510(k) K242966

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter by Gentuity, LLC — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2025
Date Received
September 26, 2024
Clearance Type
Traditional
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 Gentuity, LLC

  • K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), (August 16, 2024)
  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K192922 — Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (February 20, 2020)

Other clearances for product code DQO

  • K250751 — DualView Catheter (July 17, 2025)
  • 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)
  • K221279 — pNOVUS 21 Microcatheter (November 28, 2022)