FDA.reportPublic FDA data

510(k) K251982

Device
Edwards MC3 Tricuspid annuloplasty ring (4900)
Applicant
Edwards Lifesciences, LLC
510(k) number
K251982
Product code
KRH
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-23
Date received
2025-06-27
Regulation
870.3800
Classification name
Ring, Annuloplasty
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Derrick Dukatz
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.2026-04-14
K253232Seguin Annuloplasty RingABBOTT MEDICAL2025-10-29
K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC2025-09-17
K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.2025-07-25
K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.2024-04-09
K230679WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc.2023-05-26
K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty RingCorcym S.r.l.2023-04-07
K202253TruForm Sievers Annuloplasty RingGenesee Biomedical, Inc.2020-10-06
K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingMedtronic, Inc.2020-07-01
K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC2019-12-16
K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc.2019-04-18
K181132Tri-Ad 2.0 Adams Tricuspid BandMedtronic2018-05-29
K180411MEMO 4DSorin Group Italia S.R.L.2018-03-16
K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc.2016-10-12
K142221MEMO 3D ReChordSorin Group Italia S.R.L.2014-08-29