Ring, Annuloplasty
FDA product code KRH · Class II (moderate risk) · 21 CFR 870.3800 · Cardiovascular
75510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
- Genesee Biomedical, Inc. 13
- St Jude Medical 10
- Edwards Lifesciences, LLC 9
- Medtronic, Inc. 4
- Baxter Healthcare Corp 4
- Medtronic Heart Valves 3
- The Heart Valve Div. Medtronic Cardiovascular Surg 3
- Sulzer Carbomedics, Inc. 3
- Corcym S.r.l. 3
- Medtronic Vascular 3
- Sorin Group Italia S.R.L. 2
- Shiley, Inc. 2
- Pioneering Technologies, Inc. 1
- Shelhigh, Inc. 1
- Carbomedics, Inc. 1
- Abbott Medical 1
- Medtronic Blood Systems, Inc. 1
- American Edwards Laboratories 1
- Usifroid 1
- Edwards Laboratories 1
510(k) clearances
| 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 |
| 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 |
| K192762 | Physio Flex Annuloplasty RingKRH · Traditional | Edwards Lifesciences, LLC | 12/16/2019SE |
| K190506 | NeoForm Annuloplasty RingKRH · Traditional | Genesee Biomedical, Inc. | 04/18/2019SE |
| K181132 | Tri-Ad 2.0 Adams Tricuspid BandKRH · Special | Medtronic | 05/29/2018SE |
| K180411 | Memo 4DKRH · Special | Sorin Group Italia S.R.L. | 03/16/2018SE |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandKRH · Traditional | Genesee Biomedical, Inc. | 10/12/2016SE |
| K142221 | MEMO 3D ReChordKRH · Special | Sorin Group Italia S.R.L. | 08/29/2014SE |
| K103520 | Carpentier-Edwards Physio Tricuspid Annuloplasty RingKRH · Traditional | Edwards Lifesciences, LLC | 06/24/2011SE |
| K103812 | Mitra-LiftKRH · Traditional | Sciencity Co., Ltd. | 05/18/2011SE |
| K101212 | Medtronic Contour 3D Annuloplasty Ring, Model 690RKRH · Traditional | Medtronic, Inc. | 08/07/2010SE |
| K093903 | Ats Tri-Ad Semi-Flexible Tricuspid Anuuloplasty, Model 900SFCKRH · Special | Genesee Biomedical, Inc. | 07/15/2010SE |
| K092876 | SJM Attune Annuloplasty RingKRH · Special | St Jude Medical | 10/16/2009SE |
| K092310 | Seguin Annuloplasty RingKRH · Special | St Jude Medical | 08/27/2009SE |
| K090428 | Ats Simulus Adjustable Flexible Annuloplasty, Model 735 AcKRH · Special | Genesee Biomedical, Inc. | 05/07/2009SE |
| K083623 | Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100KRH · Traditional | Edwards Lifesciences, LLC | 04/15/2009SE |
| K083191 | Detlogix Annuloplasty Ring, Model: 5100KRH · Traditional | Edwards Lifesciences, LLC | 04/10/2009SE |
| K083683 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SCKRH · Special | Genesee Biomedical, Inc. | 02/25/2009SE |
| K083835 | Attune Adjustable Flexible Annuloplasty Ring Model AfrKRH · Special | St Jude Medical | 01/23/2009SE |
| K083470 | Carpentier- Edwards Physio II Annuloplasty, Model 5200KRH · Traditional | Edwards Lifesciences, LLC | 01/23/2009SE |
| K070488 | Micardia Annuloplasty Band DRKRH · Traditional | Micardia Corporation | 09/04/2008SE |
| K073324 | Medtronic Profile 3D Annuloplasty Ring, Model 680RKRH · Traditional | Medtronic, Inc. | 03/13/2008SE |
| K072655 | Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SRKRH · Special | Genesee Biomedical, Inc. | 10/23/2007SE |
| K071327 | Memo 3D Semirigid Annuloplasty RingKRH · Traditional | Sorin Biomedica Cardio S.R.L. | 08/10/2007SE |
| K071281 | Uniring - Annuloplasty Ring with SizersKRH · Traditional | Peters Surgical | 08/03/2007SE |
| K071214 | Ats Simulus Adjustable Flexible Annuloplasty RingKRH · Special | Genesee Biomedical, Inc. | 07/31/2007SE |
| K061127 | CG Future Annuloplasty System, Model 638RKRH · Special | Medtronic Vascular | 05/23/2006SE |
| K052970 | Simplici-T Annuloplasty SystemKRH · Special | Medtronic Heart Valves | 01/11/2006SE |
| K052899 | Ats Simulus Annuloplasty Band, Model 700FCKRH · Special | Genesee Biomedical, Inc. | 11/17/2005SE |
| K052565 | Ats Simulus Annuloplasty Ring, Model 700FFKRH · Special | Genesee Biomedical, Inc. | 11/17/2005SE |
| K052860 | CG Future Annuloplasty BandKRH · Special | Medtronic Heart Valves | 11/10/2005SE |
| K042734 | SJM Rigid Saddle Ring Model Rsar-(Size)KRH · Traditional | St. Jude Medical, Inc. | 12/17/2004SE |
| K033685 | Northrup Universal Annuloplasty System, Model 1000KRH · Traditional | Medical Cv, Inc. | 08/03/2004SE |
| K032810 | Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore…KRH · Traditional | Medtronic Heart Valves | 12/05/2003SE |
| K032250 | Geoform Annuloplasty Ring, Mitral Model 4200KRH · Special | Edwards Lifesciences, LLC | 08/26/2003SE |
| K023940 | Shelhigh BioringKRH · Traditional | Shelhigh, Inc. | 06/04/2003SE |
| K023185 | Annuloflex Annuoplasty System, Model Af 800KRH · Traditional | Sulzer Carbomedics, Inc. | 12/17/2002SE |
| K022363 | SJM Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)KRH · Special | St. Jude Medical, Inc. | 09/19/2002SE |
| K021051 | Annuloflo System, Mitral Model AR700KRH · Special | Sulzer Carbomedics, Inc. | 04/23/2002SE |
| K020864 | Edwards MC Tricuspid Annuloplasty System, Model 4900KRH · Special | Edwards Lifesciences, LLC | 04/17/2002SE |
| K014161 | SJM Tailor Annuloplasty Ring Model Tarp- (Size)KRH · Special | St. Jude Medical, Inc. | 01/15/2002SE |
| K014037 | SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size)KRH · Special | St. Jude Medical, Inc. | 01/04/2002SE |
| K011395 | Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638BKRH · Special | Medtronic Vascular | 07/12/2001SE |
| K000119 | SJM Tailor Annuloplasty Ring, Model TarnKRH · Special | St. Jude Medical, Inc. | 02/17/2000SE |
| K992056 | Annuloflex Annuloplasty System, Model AF800KRH · Traditional | Sulzer Carbomedics, Inc. | 10/12/1999SE |
| K984435 | Medtronic Khonsari Annuloplasty Band, Model H609MKRH · Special | Medtronic Vascular | 01/07/1999SE |
| K980487 | Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525…KRH · Traditional | Baxter Edwards | 07/07/1998SE |
| K980534 | Duran Flexible Annuloplasty Ring Model Number H608HKRH · Traditional | The Heart Valve Div. Medtronic Cardiovascular Surg | 04/30/1998SE |
| K970375 | Annuloflo SystemKRH · Traditional | Carbomedics, Inc. | 07/25/1997ST |
| K961246 | SJM Seguin Annuloplasty Ring Model Sar-MKRH · Traditional | St. Jude Medical, Inc. | 02/14/1997ST |
| K960356 | Posterior Annuloplasty Band (Model 607)KRH · Traditional | The Heart Valve Div. Medtronic Cardiovascular Surg | 08/27/1996ST |
| K926138 | Carpentier-Edwards Physio Annuloplasty RingKRH · Traditional | Baxter Healthcare Corp | 06/22/1993SESP |
| K923367 | Cosgrove Edwards Annuloplasty System, Model 4600KRH · Traditional | Baxter Healthcare Corp | 01/06/1993SESP |
| K905175 | Pti Annuloplasty Ring(Sterile)KRH · Traditional | Pioneering Technologies, Inc. | 02/14/1992SE |
| K914972 | Carpentier-Edwards(R) Flex Annul Ring, 4500 TricusKRH · Traditional | Baxter Healthcare Corp | 01/09/1992SE |
| K914602 | Duran Flex Annuloplasty Ring/Obtur H601H, ModifiedKRH · Traditional | The Heart Valve Div. Medtronic Cardiovascular Surg | 11/22/1991SE |
| K912554 | Annuloplasty Rings, Model 4400 Mirtal and 4500 TriKRH · Traditional | Baxter Healthcare Corp | 09/09/1991SE |
| K902159 | Biflex(Tm) Annuloplasty RingKRH · Traditional | St. Jude Medical, Inc. | 01/18/1991SE |
| K893678 | Duran Flexible Annuloplasty Ring & Obturator H601HKRH · Traditional | Medtronic Blood Systems, Inc. | 11/27/1989SE |
| K831949 | Prosthetic Rings #4400 Mitral & 4500KRH · Traditional | American Edwards Laboratories | 07/29/1983PT |
| K821261 | Puig Massana-Shiley Annuloplasty RingKRH · Traditional | Shiley, Inc. | 06/16/1982SE |
| K801879 | Puig Massana-Shiley Annuloplasty RingKRH · Traditional | Shiley, Inc. | 12/16/1980SE |
| K800147 | Flexible Linear Reducer F/Mitral & Tric.KRH · Traditional | Usifroid | 04/24/1980SE |
| K792441 | Carpentier-Edwards Flex. AnnuloplastyKRH · Traditional | Edwards Laboratories | 03/17/1980PT |
| K792646 | Amp Direct Vascular Monitoring SystemKRH · Traditional | American Medical Products, Inc. | 02/11/1980SE |
| K790534 | Mersilene SuturesKRH · Traditional | Hancock Laboratories, Inc. | 03/26/1979SE |