NxStage System One Plus

Dialyzer, High Permeability With Or Without Sealed Dialysate System

NxStage Medical, Inc

The following data is part of a premarket notification filed by Nxstage Medical, Inc with the FDA for Nxstage System One Plus.

Pre-market Notification Details

Device IDK170469
510k NumberK170469
Device Name:NxStage System One Plus
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NxStage Medical, Inc 350 Merrimack Street Lawrence,  MA  01843
ContactRandall Covill
CorrespondentRandall Covill
NxStage Medical, Inc 350 Merrimack Street Lawrence,  MA  01843
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-16
Decision Date2017-05-09
Summary:summary

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