Cleared Abbreviated

Carpentier-Edwards Physio Annuloplasty Ring (4450)

K251688 · Edwards Lifesciences, LLC · Cardiovascular
Sep 2025
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K251688 is an FDA 510(k) clearance for the Carpentier-Edwards Physio Annuloplasty Ring (4450), 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 17, 2025, 107 days after receiving the submission on June 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K251688 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2025
Decision Date September 17, 2025
Days to Decision 107 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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