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FDA 510(k)

Inspire HCR and HCR DUAL cardiotomy reservoirs

K-Number: K251783 · 2025-12-22

ApplicantSorin Group Italia S.R.L.
Decision Date2025-12-22
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Inspire HCR and HCR DUAL cardiotomy reservoirs is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-22 under approval number K251783. 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 HCR and HCR DUAL cardiotomy reservoirs?

Inspire HCR and HCR DUAL cardiotomy reservoirs is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K251783.

When was Inspire HCR and HCR DUAL cardiotomy reservoirs approved by the FDA?

Inspire HCR and HCR DUAL cardiotomy reservoirs received FDA 510(k) clearance on 2025-12-22, under approval number K251783.

What company makes Inspire HCR and HCR DUAL cardiotomy reservoirs?

Inspire HCR and HCR DUAL cardiotomy reservoirs is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for Inspire HCR and HCR DUAL cardiotomy reservoirs?

The FDA product code for Inspire HCR and HCR DUAL cardiotomy reservoirs is DTN.

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Related Devices (Code: DTN)

K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L. 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

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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