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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K170583.

When did Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface receive FDA 510(k) clearance?

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface received FDA 510(k) clearance on 2017-03-17, under 510(k) number K170583.

Who is the listed applicant for Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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Related Devices (Code: DTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac SurgeryK223361BMR 1900 PHISIOSorin Group Italia S.R.L.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

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.

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