KRH — Ring, Annuloplasty Class II
FDA product code KRH covers "Ring, Annuloplasty", a Class II medical device regulated under 21 CFR 870.3800. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261707 | corcym | MEMO 4D Curve Semirigid mitral annuloplasty ring | June 18, 2026 |
| K260498 | corcym | TriMemo SEMIRIGID ANNULOPLASTY RING | April 14, 2026 |
| 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 |