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510(k) K252527

Surfacer Inside-Out Access Catheter System by Merit Medical System, Inc. — Product Code QJH

Clearance Details

Decision
SESU ()
Decision Date
September 10, 2025
Date Received
August 11, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reverse Central Venous Recanalization System
Device Class
Class II
Regulation Number
870.1342
Review Panel
CV
Submission Type

A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.

Other clearances by Merit Medical System, Inc.

  • K231468 — SCOUT MD Surgical Guidance System (February 12, 2024)
  • K230636 — Maestro Microcatheter (March 30, 2023)
  • K212817 — Merit Siege Vascular Plug (December 15, 2021)
  • K193571 — Go2Wire Guide Wire (April 8, 2020)

Other clearances for product code QJH

  • DEN190038 — Surfacer Inside-Out Access Catheter System (February 10, 2020)