Home / 510(k) Clearances / K173114

510(k) K173114

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2018
Date Received
September 29, 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 Pfm Medical, Inc.

  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)
  • K241278 — ASEPT® Glide Peritoneal Drainage System (January 14, 2025)
  • K221779 — ASEPT Peritoneal Drainage System (May 2, 2023)
  • K213666 — NuCath Wedge Pressure Catheter (October 6, 2022)
  • K201137 — Asept Surgical Face Mask (August 19, 2020)
  • K192802 — primeMidline Catheters (October 28, 2019)
  • K140137 — SAFETY BIOPSY NEEDLE SYSTEM (March 25, 2014)
  • K122402 — LPP (LOW PROFILE PORT) (July 16, 2013)
  • K113354 — VETA PERITONEAL DIALYSIS CATHETER (March 13, 2012)
  • K110914 — TRIPLE LUMEN PFM PICC (September 21, 2011)

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)
  • 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)