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510(k) K232609

Micro Ace™ Advanced Micro Access System by Merit Medical Systems, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
August 28, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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  • 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)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vasc (May 2, 2024)

Other clearances for product code DRE

  • K253616 — ProtekDilate Vascular Access Kit (December 19, 2025)
  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)
  • K201288 — ExpanSure Large Access Transseptal Dilator (June 12, 2020)