Home / 510(k) Clearances / K233268

510(k) K233268

Impress Angiographic Catheter by Merit Medical Systems, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2024
Date Received
September 29, 2023
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 Merit Medical Systems, Inc.

  • K251802 — STAR RF Ablation System (February 13, 2026)
  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 2025)
  • K250909 — Prelude Wave Hydrophilic Sheath Introducer (April 25, 2025)
  • K242873 — Ventrax™ Delivery System (January 15, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241521 — Prelude Small O.D. Introducer Guide Wire (December 10, 2024)
  • K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vasc (May 2, 2024)
  • K233813 — Bearing nsPVA Express™ (December 21, 2023)

Other clearances for product code DQO

  • K250751 — DualView Catheter (July 17, 2025)
  • K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (January 31, 2025)
  • K242420 — pNOVUS 21 Microcatheter (November 12, 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)