Cleared Traditional

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

K161313 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital

Aug 2016

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K161313 is an FDA 510(k) clearance for the ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on August 24, 2016, 106 days after receiving the submission on May 10, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K161313 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2016
Decision Date	August 24, 2016
Days to Decision	106 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.