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510(k) K243383

CHIKAI Nexus 014 by Asahi Intecc Co., Ltd. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2025
Date Received
October 31, 2024
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 Asahi Intecc Co., Ltd.

  • K252011 — CHIKAI Nexus petit (February 2, 2026)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)
  • K243733 — SION blue PLUS (April 2, 2025)
  • K241962 — Crossloop (March 27, 2025)
  • K242597 — CROSSLEAD 0.018inch (March 5, 2025)
  • K241702 — CROSSLEAD 0.014inch (February 6, 2025)
  • K241801 — Tornus ES (December 17, 2024)
  • K241510 — CROSSLEAD Tracker (August 14, 2024)
  • K241158 — ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 (June 25, 2024)

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)
  • 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)
  • K222690 — SmartGUIDE deflectable hydrophilic guidewire (April 24, 2023)