FDA 510(k)

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

Número K: K252533 · 2025-12-18

Data da decisão2025-12-18

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252533. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Edwards Lifesciences. The 510(k) number is K252533.

When did HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) receive FDA 510(k) clearance?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252533.

Who is the listed applicant for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

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 Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

The FDA product code for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is DQK.

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Outros registros que listam Edwards Lifesciences como candidato(a)

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 K253034HemoSphere Stream Module 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 os 17 dispositivos →

Dispositivos Relacionados (Código: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Sistema de Mapeamento Integrado da AfferaMedtronic, 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

Fonte oficial

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