KRH — Ring, Annuloplasty Class II
FDA Device Classification
Classification Details
- Product Code
- KRH
- Device Class
- Class II
- Regulation Number
- 870.3800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253232 | abbott medical | Seguin Annuloplasty Ring | October 29, 2025 |
| K251982 | edwards lifesciences | Edwards MC3 Tricuspid annuloplasty ring (4900) | September 23, 2025 |
| K251688 | edwards lifesciences | Carpentier-Edwards Physio Annuloplasty Ring (4450) | September 17, 2025 |
| K250859 | genesee biomedical | TransForm McCarthy Mitral Annuloplasty Ring (TF) | July 25, 2025 |
| K232599 | genesee biomedical | TransForm McCarthy Mitral Annuloplasty Ring (TF) | April 9, 2024 |
| K230679 | genesee biomedical | WellsForm Tricuspid Annuloplasty Band (WF) | May 26, 2023 |
| K230318 | corcym | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring | April 7, 2023 |
| K202253 | genesee biomedical | TruForm Sievers Annuloplasty Ring | October 6, 2020 |
| K201449 | medtronic | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuFo | July 1, 2020 |
| K192762 | edwards lifesciences | Physio Flex Annuloplasty Ring | December 16, 2019 |
| K190506 | genesee biomedical | NeoForm Annuloplasty Ring | April 18, 2019 |
| K181132 | medtronic | Tri-Ad 2.0 Adams Tricuspid Band | May 29, 2018 |
| K180411 | sorin group italia | MEMO 4D | March 16, 2018 |
| K161815 | genesee biomedical | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | October 12, 2016 |
| K142221 | sorin group italia | MEMO 3D ReChord | August 29, 2014 |
| K103520 | edwards lifesciences | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | June 24, 2011 |
| K103812 | sciencity co | MITRA-LIFT | May 18, 2011 |
| K101212 | medtronic | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | August 7, 2010 |
| K093903 | genesee biomedical | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | July 15, 2010 |
| K092876 | st jude medical | SJM ATTUNE ANNULOPLASTY RING | October 16, 2009 |