SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Quanta Dialysis Technologies Ltd

The following data is part of a premarket notification filed by Quanta Dialysis Technologies Ltd with the FDA for Sc+ Hemodialysis Device, Sc+ Dialysate Cartridge, Sc+ Blood Tube Set.

Pre-market Notification Details

Device IDK222067
510k NumberK222067
Device Name:SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Quanta Dialysis Technologies Ltd Tything Road Alcester,  GB B49 6EU
ContactSam Drew
CorrespondentSam Drew
Quanta Dialysis Technologies Ltd Tything Road Alcester,  GB B49 6EU
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-13
Decision Date2022-11-10

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