Home / 510(k) Clearances / K201487

510(k) K201487

Traxcess 7 Mini Guidewire by MicroVention, Inc. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2020
Date Received
June 4, 2020
Clearance Type
Special
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 MicroVention, Inc.

  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K232542 — Wedge XL Delivery Catheter (May 16, 2024)
  • K230775 — SOFIA EX Intracranial Support Catheter (September 14, 2023)
  • K222694 — EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (April 27, 2023)
  • K222115 — ISAAC Neurovascular Navigation Catheter (January 10, 2023)
  • K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880 (December 21, 2022)
  • K214024 — SOFIA 88 Catheter (September 12, 2022)
  • K211120 — ERIC Retrieval Device (March 31, 2022)
  • K193607 — BOBBY Balloon Guide Catheter (July 21, 2020)
  • K200547 — Traxcess 14 SELECT Guidewire (April 16, 2020)

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)