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510(k) K160018

Arrow Quickflash Arterial Catheterization Device by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2016
Date Received
January 5, 2016
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

Other clearances by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

  • K180395 — EZ-IO Intraosseous Vascular Access System (November 9, 2018)
  • K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System (February 24, 2017)
  • K161313 — ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and An (August 24, 2016)
  • K153487 — CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (February 4, 2016)
  • K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (January 28, 2016)
  • K152272 — Arrow Endurance Extended Dwell Peripheral Catheter System (November 23, 2015)
  • K143102 — Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (July 24, 2015)

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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)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)