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510(k) K171483

ArchFlo CT Midline by Medcomp (Dba Medical Components, Inc.) — Product Code PND

K171483 is an FDA 510(k) premarket notification submitted by Medcomp (Dba Medical Components, Inc.) for the device "ArchFlo CT Midline". The FDA issued a decision of Substantially Equivalent on December 15, 2017. The device falls under product code PND (Midline Catheter), a Class II device regulated under 21 CFR 880.5200. Medcomp (Dba Medical Components, Inc.) has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2017
Date Received
May 22, 2017
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 Medcomp (Dba Medical Components, Inc.)

  • K171618 — Symetrex Long Term Hemodialysis Catheter (November 16, 2017)
  • K171333 — 20G x 5/8 Pro-Lock CT Safety Infusion Set (July 18, 2017)

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)
  • K170770 — CT Midline (July 25, 2017)
  • K170158 — PowerGlide ST Midline Catheter (June 1, 2017)
  • K162900 — PowerMidline Catheter (December 14, 2016)

FDA data resources