INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR

Oxygenator, Cardiopulmonary Bypass

SORIN GROUP ITALIA S.R.L.

The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Inspire 8f Oxygenator With Integrated Arterial Filter & Hardshell Reservoir.

Pre-market Notification Details

Device IDK121536
510k NumberK121536
Device Name:INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada,  CO  80004
ContactScott Light
CorrespondentScott Light
SORIN GROUP ITALIA S.R.L. 14401 W. 65TH WAY Arvada,  CO  80004
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-24
Decision Date2012-08-22
Summary:summary

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