Cleared Traditional

Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions

K143102 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Gastroenterology & Urology

Jul 2015

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K143102 is an FDA 510(k) clearance for the Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions, a Catheter, Hemodialysis, Triple Lumen, Non-implanted (Class II — Special Controls, product code NIE), submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on July 24, 2015, 268 days after receiving the submission on October 29, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K143102 FDA.gov
FDA Decision	Cleared SEKD
Date Received	October 29, 2014
Decision Date	July 24, 2015
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	NIE — Catheter, Hemodialysis, Triple Lumen, Non-implanted
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5540
Definition	Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion.