Cleared Traditional

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

K242451 · Edwards Lifesciences · Cardiovascular
Dec 2024
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K242451 is an FDA 510(k) clearance for the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100), a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on December 9, 2024, 115 days after receiving the submission on August 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K242451 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2024
Decision Date December 09, 2024
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYG — Catheter, Flow Directed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1240

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