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FDA 510(k)

Edwards MC3 Tricuspid annuloplasty ring (4900)

K-Number: K251982 · 2025-09-23

ApplicantEdwards Lifesciences, LLC
Decision Date2025-09-23
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards MC3 Tricuspid annuloplasty ring (4900) is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-09-23 under approval 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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K251982.

When was Edwards MC3 Tricuspid annuloplasty ring (4900) approved by the FDA?

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

What company makes Edwards MC3 Tricuspid annuloplasty ring (4900)?

Edwards MC3 Tricuspid annuloplasty ring (4900) is manufactured by Edwards Lifesciences, LLC.

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

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT04634266 TRICuspid Intervention in Heart Failure Trial ACTIVE_NOT_RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT04221490 2019-06 TRISCEND Study ACTIVE_NOT_RECRUITING NCT06479824 NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study SUSPENDED

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Related Devices (Code: KRH)

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc. K181132Tri-Ad 2.0 Adams Tricuspid BandMedtronic K180411MEMO 4DSorin Group Italia S.R.L. K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. K202253TruForm Sievers Annuloplasty RingGenesee 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.

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