KRH
- Product code
- KRH
- Device name
- Ring, Annuloplasty
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3800
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 75 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261707 | 2026-06-18 | Corcym S.r.l. | MEMO 4D Curve Semirigid mitral annuloplasty ring | |
| K260498 | 2026-04-14 | Corcym S.r.l. | TriMemo SEMIRIGID ANNULOPLASTY RING | |
| K253232 | 2025-10-29 | ABBOTT MEDICAL | Seguin Annuloplasty Ring | |
| K251982 | 2025-09-23 | Edwards Lifesciences, LLC | Edwards MC3 Tricuspid annuloplasty ring (4900) | |
| K251688 | 2025-09-17 | Edwards Lifesciences, LLC | Carpentier-Edwards Physio Annuloplasty Ring (4450) | FDA |
| K250859 | 2025-07-25 | Genesee Biomedical, Inc. | TransForm McCarthy Mitral Annuloplasty Ring (TF) | |
| K232599 | 2024-04-09 | Genesee Biomedical, Inc. | TransForm McCarthy Mitral Annuloplasty Ring (TF) |
Official FDA classification page: KRH
Classification and pathway per current FDA publications. Data from openFDA (CC0).