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510(k) Data Aggregation
K Number
K253232Device Name
Seguin Annuloplasty RingManufacturer
Date Cleared
2025-10-29
(30 days)
Product Code
Regulation Number
870.3800Type
SpecialPanel
CardiovascularReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Seguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.
Device Description
The Seguin Annuloplasty Ring (SARP) is a semi-rigid or semi-flexible annuloplasty ring designed to support mitral valve repair. The ring is constructed from a polyethylene core covered by a knitted polyester sewing cuff. The Seguin Ring is sterilized by EO sterilization and supplied sterile. The Seguin ring is offered in sizes 24-40mm in increments of 2 mm.
AI/ML Overview
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