Device Listing 2057322835

Listing Summary#

Listing key
2057322835
Premarket submission
K242451
Device
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
Applicant
Edwards Lifesciences
Product code
DYG
Decision date
2024-12-09