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HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242451

by Edwards Lifesciences

Identifiers

510(k) Number
K242451 FDA 510(k)
FDA Product Code
DYG FDA 510(k)
Models / Variants
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) FDA 510(k)
HemoSphere Alta- monitor pressure cable (HEMAPSC200) FDA 510(k)
Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1240 FDA 510(k)
Regulation Number
870.1240 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more … by Edwards Lifesciences — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences

Sources (1)

  • FDA 510(k) K242451 24 fields · synced Jun 18, 2026