Home / 510(k) Clearances / K210047

510(k) K210047

Stiletto Extended Dwell Catheter by Piper Access, LLC — Product Code PND

K210047 is an FDA 510(k) premarket notification submitted by Piper Access, LLC for the device "Stiletto Extended Dwell Catheter". The FDA issued a decision of Substantially Equivalent on August 27, 2021. The device falls under product code PND (Midline Catheter), a Class II device regulated under 21 CFR 880.5200. Piper Access, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2021
Date Received
January 8, 2021
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 Piper Access, LLC

  • K191976 — Piper GO-IO Intraosseous Infusion System (November 13, 2019)
  • K181904 — 5 FR Dual Lumen Piper PICC (September 25, 2018)

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)
  • 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)

FDA data resources