PrisMax System Version 3

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismax System Version 3.

Pre-market Notification Details

Device IDK193482
510k NumberK193482
Device Name:PrisMax System Version 3
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Baxter Healthcare Corporation 7601 Northland Drive Brooklyn Park,  MN  55428
ContactChristopher Scavotto
CorrespondentChristopher Scavotto
Baxter Healthcare Corporation 7601 Northland Drive Brooklyn Park,  MN  55428
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-03-13

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