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510(k) K213203

Provena(TM) Midline Catheter by C.R. Bard, Inc. — Product Code PND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
September 29, 2021
Clearance Type
Special
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)
  • K213855 — Arrow Pressure Injectable Midline Catheter (September 2, 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)
  • K162900 — PowerMidline Catheter (December 14, 2016)