WellsForm Tricuspid Annuloplasty Band (WF)
FDA 510(k) K230679 · Genesee Biomedical, Inc.
510(k) numberK230679
Submission
- Device name
- WellsForm Tricuspid Annuloplasty Band (WF)
- Applicant
- Genesee Biomedical, Inc.
Denver, CO, US - Received
- March 13, 2023
- Decision date
- May 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated | Edwards Lifesciences, LLC | 09/23/2025SE |
| 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 |
| 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 |
|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD)PZX · Traditional | 05/22/2026SE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | 07/25/2025SE |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | 04/09/2024SE |
| K202253 | TruForm Sievers Annuloplasty RingKRH · Traditional | 10/06/2020SE |
| K190506 | NeoForm Annuloplasty RingKRH · Traditional | 04/18/2019SE |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandKRH · Traditional | 10/12/2016SE |
| K093903 | Ats Tri-Ad Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCKRH · Special | 07/15/2010SE |
| K090428 | Ats Simulus Adjustable Flexible Annuloplasty, Model 735 AcKRH · Special | 05/07/2009SE |
| K083683 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SCKRH · Special | 02/25/2009SE |
| K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRKRH · Special | 10/23/2007SE |
Questions and answers
When was WellsForm Tricuspid Annuloplasty Band (WF) cleared by the FDA?
WellsForm Tricuspid Annuloplasty Band (WF) (K230679) received a 510(k) decision of Substantially Equivalent on May 26, 2023, 74 days after the submission was received.
What is the product code of K230679?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.