HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more— 510(k) K242451

Clearance details

Device name as filed

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

Code DYG

Device class

Class 2

Regulation

21 CFR 870.1240

Advisory panel

Cardiovascular

Date received

2024-08-16

Decision date

2024-12-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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• K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)2025-12-18
• K253034 — HemoSphere Stream Module2025-10-21

Death

18

Malfunction

1,051

Other

1

Total

1,070

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →