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510(k) K161313

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — Product Code PND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2016
Date Received
May 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Midline Catheter
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.

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)
  • K160018 — Arrow Quickflash Arterial Catheterization Device (June 13, 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)

Other clearances for product code PND

  • K252402 — Midline Catheter (December 18, 2025)
  • K213855 — Arrow Pressure Injectable Midline Catheter (September 2, 2022)
  • K213203 — Provena(TM) Midline Catheter (May 13, 2022)
  • K210047 — Stiletto Extended Dwell Catheter (August 27, 2021)
  • K192802 — primeMidline Catheters (October 28, 2019)
  • K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 (November 2, 2018)
  • K173114 — primeMidline Catheters (March 7, 2018)
  • K171483 — ArchFlo CT Midline (December 15, 2017)
  • K170770 — CT Midline (July 25, 2017)
  • K170158 — PowerGlide ST Midline Catheter (June 1, 2017)