PrisMax System Version 2

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Baxter Healthcare Corp

The following data is part of a premarket notification filed by Baxter Healthcare Corp with the FDA for Prismax System Version 2.

Pre-market Notification Details

Device IDK190910
510k NumberK190910
Device Name:PrisMax System Version 2
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Baxter Healthcare Corp 7601 Northland Drive Suite 170 Brooklyn Park,  MN  55428
ContactChris Scavotto
CorrespondentChris Scavotto
Baxter Healthcare Corp 7601 Northland Drive Suite 170 Brooklyn Park,  MN  55428
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-08
Decision Date2019-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414123933 K190910 000
00085412639505 K190910 000
00085412639499 K190910 000

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