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510(k) K213855

Arrow Pressure Injectable Midline Catheter by Arrow International, LLC Subsidiary of Teleflex Incorporated — Product Code PND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2022
Date Received
December 10, 2021
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.

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  • 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)
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  • K170158 — PowerGlide ST Midline Catheter (June 1, 2017)
  • K162900 — PowerMidline Catheter (December 14, 2016)