Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K-Number: K170583 · 2017-03-17
ApplicantMedtronic, Inc.
Decision Date2017-03-17
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2017-03-17 under approval number K170583. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is a medical device that received FDA 510(k) clearance on 2017-03-17. It is manufactured by Medtronic, Inc.. The 510(k) number is K170583.
When was Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface approved by the FDA?
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface received FDA 510(k) clearance on 2017-03-17, under approval number K170583.
What company makes Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is manufactured by Medtronic, Inc..
What is the FDA product code for Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?
The FDA product code for Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is DTN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.