Cleared Traditional

Arrow Pressure Injectable Midline Catheter

K213855 · Arrow International, LLC Subsidiary of Teleflex Incorporated · General Hospital

Sep 2022

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K213855 is an FDA 510(k) clearance for the Arrow Pressure Injectable Midline Catheter, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Arrow International, LLC Subsidiary of Teleflex Incorporated (Morrisville, US). The FDA issued a Cleared decision on September 2, 2022, 266 days after receiving the submission on December 10, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K213855 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2021
Decision Date	September 02, 2022
Days to Decision	266 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PND — Midline Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.