Seguin Annuloplasty Ring
K-Number: K253232 · 2025-10-29
ApplicantABBOTT MEDICAL
Decision Date2025-10-29
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Seguin Annuloplasty Ring is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-10-29 under approval number K253232. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Seguin Annuloplasty Ring?
Seguin Annuloplasty Ring is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K253232.
When was Seguin Annuloplasty Ring approved by the FDA?
Seguin Annuloplasty Ring received FDA 510(k) clearance on 2025-10-29, under approval number K253232.
What company makes Seguin Annuloplasty Ring?
Seguin Annuloplasty Ring is manufactured by ABBOTT MEDICAL.
What is the FDA product code for Seguin Annuloplasty Ring?
The FDA product code for Seguin Annuloplasty Ring is KRH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.