Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K213855Substantially Equivalent

Arrow Pressure Injectable Midline Catheter

Arrow International LLC (subsidiary of Teleflex Incorporated), Morrisville NC / Traditional, Substantially Equivalent

K213855 is the FDA 510(k) clearance record for Arrow Pressure Injectable Midline Catheter, a class II device, cleared for Arrow International, LLC Subsidiary of Teleflex Incorporated on under FDA product code PND (Midline Catheter). FDA's definition for product code PND reads: "The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days". FDA records list 23 510(k) clearances for Arrow International, LLC Subsidiary of Teleflex Incorporated, from to . As of , FDA records show one recall naming K213855.

Clearance record

Decision date
Received
(266 days to decision)
Product code
PND Midline Catheter
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Arrow International, LLC Subsidiary of Teleflex Incorporated 3015 Carrington Mill Blvd., Morrisville NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PND

Trailing 12 months
1 clearance under product code PND in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PND, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260