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510(k) K242873

Ventrax™ Delivery System by Merit Medical Systems, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2025
Date Received
September 23, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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Other clearances for product code DQY

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  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
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  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
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