Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

Hemodialyzer With Expanded Solute Removal Profile

Baxter Healthcare Corporation

The following data is part of a De Novo classification by Baxter Healthcare Corporation with the FDA for Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer.

Pre-market Notification Details

DeNovo IDDEN190042
Device Name:Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
ClassificationHemodialyzer With Expanded Solute Removal Profile
Applicant Baxter Healthcare Corporation 32650 North Wilson Road Round Lake,  IL  60073
ContactKristen Bozzelli
Product CodeQAX  
CFR Regulation Number876.5862 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2019-09-16
Decision Date2020-08-28
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000
37332414125715 DEN190042 000

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