Cleared Traditional

Pentaflush

K214080 · Pentaferte Italia S.R.L. · General Hospital

Jul 2022

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K214080 is an FDA 510(k) clearance for the Pentaflush, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Pentaferte Italia S.R.L. (Campli Teramo, IT). The FDA issued a Cleared decision on July 20, 2022, 205 days after receiving the submission on December 27, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K214080 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2021
Decision Date	July 20, 2022
Days to Decision	205 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NGT — Saline, Vascular Access Flush
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.