Cleared Traditional

Power Acute Triple Lumen Hemodialysis Catheter

K222170 · Health Line International Corporation · Gastroenterology & Urology

Jan 2023

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K222170 is an FDA 510(k) clearance for the Power Acute Triple Lumen Hemodialysis Catheter, a Catheter, Hemodialysis, Triple Lumen, Non-implanted (Class II — Special Controls, product code NIE), submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on January 13, 2023, 176 days after receiving the submission on July 21, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K222170 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2022
Decision Date	January 13, 2023
Days to Decision	176 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.