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FDA 510(k)

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

K-Number: K161733 · 2017-03-08

ApplicantSorin Group Italia S.R.L.
Decision Date2017-03-08
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2017-03-08 under approval number K161733. 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 INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is a medical device that received FDA 510(k) clearance on 2017-03-08. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K161733.

When was INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C approved by the FDA?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C received FDA 510(k) clearance on 2017-03-08, under approval number K161733.

What company makes INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is DTN.

Other Devices by Sorin Group Italia S.R.L.

K162215Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae K180979PureFlex Arterial Cannulae K180411MEMO 4D K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter K190650Revolution Centrifugal Blood Pump K190690INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir

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Related Devices (Code: DTN)

K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. K223361BMR 1900 PHISIOSorin 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 Surgery K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin 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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