510(k) K253232

Seguin Annuloplasty Ring by ABBOTT MEDICAL — Product Code KRH

K253232 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Seguin Annuloplasty Ring". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.