NxStage Therapeutic Plasma Exchange (TPE) Cartridge

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 Therapeutic Plasma Exchange (tpe) Cartridge.

Pre-market Notification Details

Device IDK143313
510k NumberK143313
Device Name:NxStage Therapeutic Plasma Exchange (TPE) Cartridge
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NxStage Medical, Inc. 350 Merrimack Street Lawrence,  MA  01843
ContactRandall J Covill
CorrespondentRandall J 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 Received2014-11-19
Decision Date2015-03-20
Summary:summary

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