NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE 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 System One With Therapeutic Plasma Exchange Cartridge.

Pre-market Notification Details

Device IDK093069
510k NumberK093069
Device Name:NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
ContactMichael Doyle
CorrespondentMichael Doyle
NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-30
Decision Date2010-10-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.