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510(k) K253122

Sim&Size by Sim&Cure — Product Code PZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2025
Date Received
September 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class
Class II
Regulation Number
892.2050
Review Panel
CV
Submission Type

Visualization and measurement of blood vessels and intravascular devices for preoperational planning.

Other clearances by Sim&Cure

  • K242124 — Sim&Size (December 14, 2024)
  • K222664 — Sim&Size (January 27, 2023)
  • K212373 — Sim&Size (January 27, 2022)
  • K202322 — Sim&Size (December 31, 2020)
  • K190049 — Sim&Size (September 17, 2019)

Other clearances for product code PZO

  • K250160 — ANKYRAS (May 6, 2025)
  • K242124 — Sim&Size (December 14, 2024)
  • K230006 — Ankyras (December 28, 2023)
  • K222664 — Sim&Size (January 27, 2023)
  • K213838 — AneuGuide (June 1, 2022)
  • K212373 — Sim&Size (January 27, 2022)
  • K202322 — Sim&Size (December 31, 2020)
  • K190049 — Sim&Size (September 17, 2019)
  • K171534 — SurgicalPreview (November 8, 2017)