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510(k) K241388

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2025
Date Received
May 15, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Neurovasculature
Device Class
Class II
Regulation Number
870.1250
Review Panel
NE
Submission Type

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K243080 — Riptide Aspiration System (October 29, 2024)
  • K211990 — Rist 071 Radial Access Guide Catheter (July 27, 2021)
  • K203432 — Axium Detachable Coil; Axium Prime Detachable Coil (July 7, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 2021)
  • K202850 — Concerto Versa, Detachable Coil (February 9, 2021)
  • K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic (November 20, 2020)
  • K202318 — Marathon Flow Directed Micro Catheter (September 14, 2020)
  • K201689 — Riptide Aspiration System (July 21, 2020)
  • K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (July 21, 2020)

Other clearances for product code QJP

  • K253032 — AXS Lift Intracranial Base Catheter (February 11, 2026)
  • K252297 — Toro 88 Superbore Catheter (January 16, 2026)
  • K251097 — V-DAC Catheter (January 6, 2026)
  • K251668 — SurfRider 13 Microcatheter (January 5, 2026)
  • K252213 — Bendit17 Microcatheter (December 3, 2025)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)