Home / 510(k) Clearances / K233791

510(k) K233791

Drivewire 24 Guidewire by Rapid-Medical , Ltd. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2024
Date Received
November 28, 2023
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 Rapid-Medical , Ltd.

  • K200374 — Columbus Guidewire (December 14, 2020)
  • DEN170064 — Comaneci, Comaneci Petit, Comaneci 17 (April 24, 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)
  • K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire (August 1, 2023)
  • K222690 — SmartGUIDE deflectable hydrophilic guidewire (April 24, 2023)