INSPIRE 7FM Hollow Fiber Oxygenator With Integrated Arterial Filter, INSPIRE 7F Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, INSPIRE 7F DUAL Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Res

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 7fm Hollow Fiber Oxygenator With Integrated Arterial Filter, Inspire 7f Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, Inspire 7f Dual Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Res.

Pre-market Notification Details

Device IDK200683
510k NumberK200683
Device Name:INSPIRE 7FM Hollow Fiber Oxygenator With Integrated Arterial Filter, INSPIRE 7F Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, INSPIRE 7F DUAL Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Res
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Sorin Group Italia S.R.L. Via Statale 12 Nord, 86 Mirandola,  IT 41037
ContactLuigi Vecchi
CorrespondentLuigi Vecchi
Sorin Group Italia S.R.L. Via Statale 12 Nord, 86 Mirandola,  IT 41037
Product CodeDTZ  
Subsequent Product CodeDTM
Subsequent Product CodeDTN
Subsequent Product CodeDTP
Subsequent Product CodeDTR
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2020-06-12

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