FDA 510(k)

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

K-Nummer: K252533 · 2025-12-18

Entscheidungsdatum2025-12-18

ProduktcodeDQK

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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