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510(k) K192802

primeMidline Catheters by Pfm Medical, Inc. — Product Code PND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2019
Date Received
September 30, 2019
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.

Other clearances by Pfm Medical, Inc.

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  • K201137 — Asept Surgical Face Mask (August 19, 2020)
  • K173114 — primeMidline Catheters (March 7, 2018)
  • K140137 — SAFETY BIOPSY NEEDLE SYSTEM (March 25, 2014)
  • K122402 — LPP (LOW PROFILE PORT) (July 16, 2013)
  • K113354 — VETA PERITONEAL DIALYSIS CATHETER (March 13, 2012)
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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)
  • K213203 — Provena(TM) Midline Catheter (May 13, 2022)
  • K210047 — Stiletto Extended Dwell Catheter (August 27, 2021)
  • 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)