FDA Product Code
FDA Product Code KRH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3800
510(k) Clearances — 75 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ring | Corcym S.r.l. | 2026-06-18 | Special | PDF ↗ |
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | 2026-04-14 | Abbreviated | PDF ↗ |
| K253232 | Seguin Annuloplasty Ring | ABBOTT MEDICAL | 2025-10-29 | Special | PDF ↗ |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | 2025-09-23 | Abbreviated | PDF ↗ |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | 2025-09-17 | Abbreviated | PDF ↗ |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2025-07-25 | Traditional | PDF ↗ |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2024-04-09 | Traditional | PDF ↗ |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | 2023-05-26 | Traditional | PDF ↗ |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | Corcym S.r.l. | 2023-04-07 | Traditional | PDF ↗ |
| K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | 2020-10-06 | Traditional | PDF ↗ |
| K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | Medtronic, Inc. | 2020-07-01 | Special | PDF ↗ |
| K192762 | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | 2019-12-16 | Traditional | PDF ↗ |
| K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | 2019-04-18 | Traditional | PDF ↗ |
| K181132 | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | 2018-05-29 | Special | PDF ↗ |
| K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018-03-16 | Special | PDF ↗ |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | 2016-10-12 | Traditional | PDF ↗ |
| K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014-08-29 | Special | PDF ↗ |
| K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | Edwards Lifesciences, LLC | 2011-06-24 | Traditional | PDF ↗ |
| K103812 | MITRA-LIFT | Sciencity Co., Ltd. | 2011-05-18 | Traditional | PDF ↗ |
| K101212 | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | Medtronic, Inc. | 2010-08-07 | Traditional | PDF ↗ |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | Genesee Biomedical, Inc. | 2010-07-15 | Special | PDF ↗ |
| K092876 | SJM ATTUNE ANNULOPLASTY RING | St Jude Medical | 2009-10-16 | Special | PDF ↗ |
| K092310 | SEGUIN ANNULOPLASTY RING | St Jude Medical | 2009-08-27 | Special | PDF ↗ |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | Genesee Biomedical, Inc. | 2009-05-07 | Special | PDF ↗ |
| K083623 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 | Edwards Lifesciences, LLC | 2009-04-15 | Traditional | PDF ↗ |
| K083191 | DETLOGIX ANNULOPLASTY RING, MODEL: 5100 | Edwards Lifesciences, LLC | 2009-04-10 | Traditional | PDF ↗ |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | Genesee Biomedical, Inc. | 2009-02-25 | Special | PDF ↗ |
| K083470 | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 | Edwards Lifesciences, LLC | 2009-01-23 | Traditional | PDF ↗ |
| K083835 | ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR | St Jude Medical | 2009-01-23 | Special | PDF ↗ |
| K070488 | MICARDIA ANNULOPLASTY BAND DR | Micardia Corporation | 2008-09-04 | Traditional | PDF ↗ |
| K073324 | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R | Medtronic, Inc. | 2008-03-13 | Traditional | PDF ↗ |
| K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | Genesee Biomedical, Inc. | 2007-10-23 | Special | PDF ↗ |
| K071327 | MEMO 3D SEMIRIGID ANNULOPLASTY RING | Sorin Biomedica Cardio S.R.L. | 2007-08-10 | Traditional | PDF ↗ |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Peters Surgical | 2007-08-03 | Traditional | PDF ↗ |
| K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | Genesee Biomedical, Inc. | 2007-07-31 | Special | PDF ↗ |
| K061127 | CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R | Medtronic Vascular | 2006-05-23 | Special | PDF ↗ |
| K052970 | SIMPLICI-T ANNULOPLASTY SYSTEM | Medtronic Heart Valves | 2006-01-11 | Special | PDF ↗ |
| K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | Genesee Biomedical, Inc. | 2005-11-17 | Special | PDF ↗ |
| K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | Genesee Biomedical, Inc. | 2005-11-17 | Special | PDF ↗ |
| K052860 | CG FUTURE ANNULOPLASTY BAND | Medtronic Heart Valves | 2005-11-10 | Special | PDF ↗ |
| K042734 | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) | St. Jude Medical, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K033685 | NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 | Medical Cv, Inc. | 2004-08-03 | Traditional | PDF ↗ |
| K032810 | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE | Medtronic Heart Valves | 2003-12-05 | Traditional | PDF ↗ |
| K032250 | GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 | Edwards Lifesciences, LLC | 2003-08-26 | Special | PDF ↗ |
| K023940 | SHELHIGH BIORING | Shelhigh, Inc. | 2003-06-04 | Traditional | PDF ↗ |
| K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | Sulzer Carbomedics, Inc. | 2002-12-17 | Traditional | PDF ↗ |
| K022363 | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) | St. Jude Medical, Inc. | 2002-09-19 | Special | PDF ↗ |
| K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | Sulzer Carbomedics, Inc. | 2002-04-23 | Special | PDF ↗ |
| K020864 | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 | Edwards Lifesciences, LLC | 2002-04-17 | Special | PDF ↗ |
| K014161 | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) | St. Jude Medical, Inc. | 2002-01-15 | Special | PDF ↗ |
| K014037 | SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) | St. Jude Medical, Inc. | 2002-01-04 | Special | PDF ↗ |
| K011395 | MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B | Medtronic Vascular | 2001-07-12 | Special | PDF ↗ |
| K000119 | SJM TAILOR ANNULOPLASTY RING, MODEL TARN | St. Jude Medical, Inc. | 2000-02-17 | Special | PDF ↗ |
| K992056 | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 | Sulzer Carbomedics, Inc. | 1999-10-12 | Traditional | PDF ↗ |
| K984435 | MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M | Medtronic Vascular | 1999-01-07 | Special | PDF ↗ |
| K980487 | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM | Baxter Edwards | 1998-07-07 | Traditional | PDF ↗ |
| K980534 | DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998-04-30 | Traditional | PDF ↗ |
| K970375 | ANNULOFLO SYSTEM | Carbomedics, Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K961246 | SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M | St. Jude Medical, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K960356 | POSTERIOR ANNULOPLASTY BAND (MODEL 607) | The Heart Valve Div. Medtronic Cardiovascular Surg | 1996-08-27 | Traditional | PDF ↗ |
| K926138 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | Baxter Healthcare Corp | 1993-06-22 | Traditional | PDF ↗ |
| K923367 | COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 | Baxter Healthcare Corp | 1993-01-06 | Traditional | PDF ↗ |
| K905175 | PTI ANNULOPLASTY RING(STERILE) | Pioneering Technologies, Inc. | 1992-02-14 | Traditional | PDF ↗ |
| K914972 | CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS | Baxter Healthcare Corp | 1992-01-09 | Traditional | PDF ↗ |
| K914602 | DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED | The Heart Valve Div. Medtronic Cardiovascular Surg | 1991-11-22 | Traditional | PDF ↗ |
| K912554 | ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI | Baxter Healthcare Corp | 1991-09-09 | Traditional | PDF ↗ |
| K902159 | BIFLEX(TM) ANNULOPLASTY RING | St. Jude Medical, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K893678 | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H | Medtronic Blood Systems, Inc. | 1989-11-27 | Traditional | PDF ↗ |
| K831949 | PROSTHETIC RINGS #4400 MITRAL & 4500 | American Edwards Laboratories | 1983-07-29 | Traditional | PDF ↗ |
| K821261 | PUIG MASSANA-SHILEY ANNULOPLASTY RING | Shiley, Inc. | 1982-06-16 | Traditional | PDF ↗ |
| K801879 | PUIG MASSANA-SHILEY ANNULOPLASTY RING | Shiley, Inc. | 1980-12-16 | Traditional | PDF ↗ |
| K800147 | FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. | Usifroid | 1980-04-24 | Traditional | PDF ↗ |
| K792441 | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY | Edwards Laboratories | 1980-03-17 | Traditional | PDF ↗ |
| K792646 | AMP DIRECT VASCULAR MONITORING SYSTEM | American Medical Products, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K790534 | MERSILENE SUTURES | Hancock Laboratories, Inc. | 1979-03-26 | Traditional | PDF ↗ |
Product code KRH · Class II · Cardiovascular. Data: openFDA.