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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 the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K251783.

When did Inspire HCR and HCR DUAL cardiotomy reservoirs receive FDA 510(k) clearance?

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

Who is the listed applicant for Inspire HCR and HCR DUAL cardiotomy reservoirs?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sorin Group Italia S.R.L. as applicant

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.

K253671Dual Stage Venous CannulaeK253616ProtekDilate Vascular Access KitK250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)K242953KIDS Arterial Filters

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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.

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.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.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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