Cleared Traditional

Smart Wedge algorithm

K230579 · Edwards Lifesciences, LLC · Cardiovascular
Aug 2023
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K230579 is an FDA 510(k) clearance for the Smart Wedge 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 August 18, 2023, 169 days after receiving the submission on March 2, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K230579 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2023
Decision Date August 18, 2023
Days to Decision 169 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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