CAPIOX HEMOCONCENTRATOR

Dialyzer, High Permeability With Or Without Sealed Dialysate System

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Hemoconcentrator.

Pre-market Notification Details

Device IDK973516
510k NumberK973516
Device Name:CAPIOX HEMOCONCENTRATOR
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactSandi Hartka
CorrespondentSandi Hartka
TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-17
Decision Date1998-01-30
Summary:summary

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