Not Cleared Direct

DEN190042 - Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer (FDA 510(k) Clearance)

DEN190042 · Baxter Healthcare Corporation · Gastroenterology & Urology device
Aug 2020
Decision
347d
Days
Class 2
Risk

DEN190042 is an FDA 510(k) submission for the Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer. This device is classified as a Hemodialyzer With Expanded Solute Removal Profile (Class II - Special Controls, product code QAX).

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Not Cleared (DENG) decision on August 28, 2020.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5862. A Hemodialyzer With Expanded Solute Removal Profile Is Intended For Use As Part Of An Artificial Kidney System For The Treatment Of Patients With Renal Failure By Performing Such Therapies As Hemodialysis, Hemofiltration, And Hemodiafiltration. A Hemodialyzer With Expanded Solute Removal Profile Includes Modifications To The Semipermeable Membrane That Allows For Increased Removal Of Uremic Retention Solutes Compared With Standard High-flux Hemodialyzers Of The High Permeability Hemodialysis System Classification (21 Cfr §876.5860), Including Solutes At The Upper End Of The “middle” Molecular Weight Range (0.5 Kda To 60 Kda)..

Submission Details

510(k) Number DEN190042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 16, 2019
Decision Date August 28, 2020
Days to Decision 347 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code QAX — Hemodialyzer With Expanded Solute Removal Profile
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5862
Definition A Hemodialyzer With Expanded Solute Removal Profile Is Intended For Use As Part Of An Artificial Kidney System For The Treatment Of Patients With Renal Failure By Performing Such Therapies As Hemodialysis, Hemofiltration, And Hemodiafiltration. A Hemodialyzer With Expanded Solute Removal Profile Includes Modifications To The Semipermeable Membrane That Allows For Increased Removal Of Uremic Retention Solutes Compared With Standard High-flux Hemodialyzers Of The High Permeability Hemodialysis System Classification (21 Cfr §876.5860), Including Solutes At The Upper End Of The “middle” Molecular Weight Range (0.5 Kda To 60 Kda).