KRH · Ring, Annuloplasty
Cardiovascular · 21 CFR 870.3800 · Class 2
Overview
| Product Code | KRH |
|---|---|
| Device Name | Ring, Annuloplasty |
| Regulation | 21 CFR 870.3800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | Apr 14, 2026 | SESE |
| K253232 | Seguin Annuloplasty Ring | ABBOTT MEDICAL | Oct 29, 2025 | SESE |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | Sep 23, 2025 | SESE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | Sep 17, 2025 | SESE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Jul 25, 2025 | SESE |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | Apr 9, 2024 | SESE |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | May 26, 2023 | SESE |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | Corcym S.r.l. | Apr 7, 2023 | SESE |
| K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | Oct 6, 2020 | SESE |
| K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | Medtronic, Inc. | Jul 1, 2020 | SESE |
| K192762 | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | Dec 16, 2019 | SESE |
| K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | Apr 18, 2019 | SESE |
| K181132 | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | May 29, 2018 | SESE |
| K180411 | MEMO 4D | Sorin Group Italia S.R.L. | Mar 16, 2018 | SESE |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | Oct 12, 2016 | SESE |
| K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | Aug 29, 2014 | SESE |
| K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | Edwards Lifesciences, LLC | Jun 24, 2011 | SESE |
| K103812 | MITRA-LIFT | Sciencity Co., Ltd. | May 18, 2011 | SESE |
| K101212 | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | Medtronic, Inc. | Aug 7, 2010 | SESE |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | Genesee Biomedical, Inc. | Jul 15, 2010 | SESE |
Top Applicants
- Genesee Biomedical, Inc. — 13 clearances
- Edwards Lifesciences, LLC — 9 clearances
- St. Jude Medical, Inc. — 7 clearances
- Baxter Healthcare Corp — 4 clearances
- Medtronic Heart Valves — 3 clearances
