FDA 510(k)

Edwards MC3 Tricuspid annuloplasty ring (4900)

K-Number: K251982 · 2025-09-23

Decision Date2025-09-23

Product CodeKRH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Edwards MC3 Tricuspid annuloplasty ring (4900) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-09-23 under 510(k) number K251982. 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 Edwards MC3 Tricuspid annuloplasty ring (4900)?

Edwards MC3 Tricuspid annuloplasty ring (4900) is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251982.

When did Edwards MC3 Tricuspid annuloplasty ring (4900) receive FDA 510(k) clearance?

Edwards MC3 Tricuspid annuloplasty ring (4900) received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251982.

Who is the listed applicant for Edwards MC3 Tricuspid annuloplasty ring (4900)?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edwards MC3 Tricuspid annuloplasty ring (4900)?

The FDA product code for Edwards MC3 Tricuspid annuloplasty ring (4900) is KRH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03745313Edwards CLASP TR EFSCOMPLETED NCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITING NCT04614402Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair SystemACTIVE_NOT_RECRUITING NCT07684313TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)NOT_YET_RECRUITING NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITING NCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, LLC as applicant

PMA P230013Percutaneously Delivered Prostheses and Tricuspid Valves PMA P860057replacement Heart-valve PMA P250019Prosthesis, mitral valve, percutaneously delivered PMA P220003Mitral valve repair devices PMA P200015Pulmonary valve prosthesis percutaneously delivered PMA P150048heart-valve, non-allograft tissue

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Related Devices (Code: KRH)

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICAL K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.

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.