Device Listing 1107626168

Listing Summary#

Listing key
1107626168
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