Cleared Special

Seguin Annuloplasty Ring

K253232 · Abbott Medical · Cardiovascular
Oct 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K253232 is an FDA 510(k) clearance for the Seguin Annuloplasty Ring, a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on October 29, 2025, 30 days after receiving the submission on September 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K253232 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date October 29, 2025
Days to Decision 30 days
Submission Type Special
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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