Intersept Filtered Cardiotomy Reservoir With Cortiva BioActive Surface

Reservoir, Blood, Cardiopulmonary Bypass

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Intersept Filtered Cardiotomy Reservoir With Cortiva Bioactive Surface.

Pre-market Notification Details

Device IDK170583
510k NumberK170583
Device Name:Intersept Filtered Cardiotomy Reservoir With Cortiva BioActive Surface
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
ContactGayatri Ghadge
CorrespondentGayatri Ghadge
Medtronic, Inc. 7611 Northland Drive Minneapolis,  MN  55428
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-02-28
Decision Date2017-03-17
Summary:summary

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