Cleared Traditional

FusedCO Algorithm

K231035 · Edwards Lifesciences, LLC · Cardiovascular
Jul 2023
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K231035 is an FDA 510(k) clearance for the FusedCO Algorithm, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 12, 2023, 92 days after receiving the submission on April 11, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K231035 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2023
Decision Date July 12, 2023
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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