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510(k) K222437

Aristotle Colossus Guidewire by Scientia Vascular, Inc. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2023
Date Received
August 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Wire, Catheter, Neurovasculature
Device Class
Class II
Regulation Number
870.1330
Review Panel
NE
Submission Type

Other clearances by Scientia Vascular, Inc.

  • K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wir (April 1, 2025)
  • K242301 — Socrates 38 Catheter (December 4, 2024)
  • K223913 — Socrates Aspiration System (September 20, 2023)
  • K223560 — Plato 17 Microcatheter (August 21, 2023)
  • K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire (August 1, 2023)
  • K220398 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 (March 10, 2023)
  • K210601 — Plato 17 Microcatheter (April 28, 2021)
  • K201760 — Zoom 14 Guidewire (July 29, 2020)
  • K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Sta (October 30, 2019)
  • K183608 — Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Sta (March 22, 2019)

Other clearances for product code MOF

  • K260130 — Willow 18 Guidewire (February 13, 2026)
  • K252011 — CHIKAI Nexus petit (February 2, 2026)
  • K253168 — 0.014” Willow Guidewire (November 26, 2025)
  • K244061 — X-Wire Guidewire (August 26, 2025)
  • K243756 — 0.014” Willow Guidewire (July 17, 2025)
  • K243383 — CHIKAI Nexus 014 (April 21, 2025)
  • K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wir (April 1, 2025)
  • K240871 — Synxess Neurovascular Guidewire (November 18, 2024)
  • K233791 — Drivewire 24 Guidewire (July 11, 2024)
  • K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire (August 1, 2023)