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510(k) K212167

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire by Vascular Solutions, LLC — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2022
Date Received
July 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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  • K221470 — Langston dual lumen catheter (June 17, 2022)
  • K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold (February 9, 2022)
  • K210647 — SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcathet (April 30, 2021)
  • K193119 — Twin-Pass Dual Access Catheter (June 29, 2020)
  • K200720 — D-Stat Radial Topical Hemostat (June 26, 2020)
  • K192454 — Wattson Temporary Pacing Guidewire (January 15, 2020)
  • K191560 — Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP (August 9, 2019)

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  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
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