WellsForm Tricuspid Annuloplasty Band (WF)
FDA 510(k) clearance K230679 · decided 2023-05-26
Clearance details
- K-number
- K230679
- Device name
- WellsForm Tricuspid Annuloplasty Band (WF)
- Applicant
- Genesee Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-13
- Decision date
- 2023-05-26
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- KRH
- Device class
- 2
- Regulation number
- 870.3800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) | Corcym S.r.l. | 2026-06-18 |
| TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498) | Corcym S.r.l. | 2026-04-14 |
| Seguin Annuloplasty Ring (K253232) | ABBOTT MEDICAL | 2025-10-29 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859) | Genesee Biomedical, Inc. | 2025-07-25 |
| TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599) | Genesee Biomedical, Inc. | 2024-04-09 |
| Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318) | Corcym S.r.l. | 2023-04-07 |
| TruForm Sievers Annuloplasty Ring (K202253) | Genesee Biomedical, Inc. | 2020-10-06 |
| SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449) | Medtronic, Inc. | 2020-07-01 |
| Physio Flex Annuloplasty Ring (K192762) | Edwards Lifesciences, LLC | 2019-12-16 |
| NeoForm Annuloplasty Ring (K190506) | Genesee Biomedical, Inc. | 2019-04-18 |
Recalls involving this device
No recalls on record reference this clearance.