Edwards MC3 Tricuspid annuloplasty ring (4900)
FDA 510(k) K251982 · Edwards Lifesciences, LLC
510(k) numberK251982
Submission
- Device name
- Edwards MC3 Tricuspid annuloplasty ring (4900)
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- June 27, 2025
- Decision date
- September 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRH – Ring, Annuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ringKRH · Special | Corcym S.r.l. | 06/18/2026SE |
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RINGKRH · Abbreviated | Corcym S.r.l. | 04/14/2026SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | Abbott Medical | 10/29/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | Edwards Lifesciences, LLC | 09/17/2025SE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | Genesee Biomedical, Inc. | 07/25/2025SE |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | Genesee Biomedical, Inc. | 04/09/2024SE |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional | Genesee Biomedical, Inc. | 05/26/2023SE |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional | Corcym S.r.l. | 04/07/2023SE |
| K202253 | TruForm Sievers Annuloplasty RingKRH · Traditional | Genesee Biomedical, Inc. | 10/06/2020SE |
| K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm…KRH · Special | Medtronic, Inc. | 07/01/2020SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | 06/26/2026SE |
| K251326 | Respiration Rate algorithmBZQ · Traditional | 06/11/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | 06/05/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | 04/17/2026SE |
| K253186 | HemoSphere Nano Monitor (HSNANO1)DQK · Traditional | 02/24/2026SE |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK · Traditional | 12/18/2025SE |
| K253034 | HemoSphere Stream ModuleDQK · Special | 10/21/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | 09/17/2025SE |
| K252364 | Edwards eSheath Optima introducer setDYB · Special | 08/29/2025SE |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…DQK · Traditional | 07/23/2025SE |
Questions and answers
When was Edwards MC3 Tricuspid annuloplasty ring (4900) cleared by the FDA?
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) received a 510(k) decision of Substantially Equivalent on September 23, 2025, 88 days after the submission was received.
What is the product code of K251982?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.