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510(k) K170158

PowerGlide ST Midline Catheter by C.R. Bard, Inc. — Product Code PND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2017
Date Received
January 18, 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.

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Other clearances for product code PND

  • K252402 — Midline Catheter (December 18, 2025)
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  • 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)
  • K162900 — PowerMidline Catheter (December 14, 2016)