FDA 510(k)

Inspire HCR and HCR DUAL cardiotomy reservoirs

N.º K: K251783 · 2025-12-22

Fecha de decisión2025-12-22

Código de productoDTN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Sorin Group Italia S.R.L. como solicitante

K253671Dual Stage Venous Cannulae K253616ProtekDilate Vascular Access Kit K250610Easyflow (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

Ver todos los 24 dispositivos →

Dispositivos relacionados (Código: DTN)

K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053Bolsa de Reservo de Venas MVR™ 800 mL; Bolsa de Reservo de Venas MVR™ 1600 mL; Bolsa de Reservo de Venas MVR™ con Superficie Bioactiva Cortiva™ 800 mL; Bolsa de Reservo de Venas MVR™ con Superficie Bioactiva Cortiva™ 1600 mLMedtronic Cardiac Surgery K223361BMR 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.

Fuente oficial

Ver en la base de datos de la FDA →

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