Name: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
Brand: Edwards Lifesciences
SKU: K252533

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is an FDA 510(k)-cleared medical device (K252533) manufactured by Edwards Lifesciences. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2025. Regulation: 8.

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

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