FDA 510(k)

HemoSphere Stream Module

N.º K: K253034 · 2025-10-21

Fecha de decisión2025-10-21

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

HemoSphere Stream Module is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K253034. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HemoSphere Stream Module?

HemoSphere Stream Module is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Edwards Lifesciences. The 510(k) number is K253034.

When did HemoSphere Stream Module receive FDA 510(k) clearance?

HemoSphere Stream Module received FDA 510(k) clearance on 2025-10-21, under 510(k) number K253034.

Who is the listed applicant for HemoSphere Stream Module?

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

What is the FDA product code for HemoSphere Stream Module?

The FDA product code for HemoSphere Stream Module is DQK.

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Otros registros que enlistan a Edwards Lifesciences como solicitante

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)K260105Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts K254279Edwards eSheath+ introducer set K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)K252364Edwards eSheath Optima introducer set K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

Ver todos los 17 dispositivos →

Dispositivos relacionados (Código: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Fuente oficial

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