FDA.report

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

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

510(k) summary PDF

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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