Cleared Abbreviated

Edwards MC3 Tricuspid annuloplasty ring (4900)

K251982 · Edwards Lifesciences, LLC · Cardiovascular
Sep 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K251982 is an FDA 510(k) clearance for the Edwards MC3 Tricuspid annuloplasty ring (4900), a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on September 23, 2025, 88 days after receiving the submission on June 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K251982 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date September 23, 2025
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRH — Ring, Annuloplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3800

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