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510(k) K252317

Zenith Micro Guidewire by Suzhou Zenith Vascular SciTech Limited — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
July 25, 2025
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 Suzhou Zenith Vascular SciTech Limited

  • K243534 — Micro Catheter (July 30, 2025)

Other clearances for product code MOF

  • K260537 — Willow 24 Guidewire (March 19, 2026)
  • K252122 — DCwire Micro-guidewire (March 16, 2026)
  • 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)