FDA 510(k) Applications for Medical Device Product Code "KRH"
(Ring, Annuloplasty)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K980487 | BAXTER EDWARDS | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM | 07/07/1998 |
| K970375 | CARBOMEDICS, INC. | ANNULOFLO SYSTEM | 07/25/1997 |
| K230318 | Corcym S.r.l. | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | 04/07/2023 |
| K192762 | Edwards Lifesciences LLC | Physio Flex Annuloplasty Ring | 12/16/2019 |
| K083470 | EDWARDS LIFESCIENCES, LLC. | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 | 01/23/2009 |
| K103520 | EDWARDS LIFESCIENCES, LLC. | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | 06/24/2011 |
| K083623 | EDWARDS LIFESCIENCES, LLC. | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 | 04/15/2009 |
| K083191 | EDWARDS LIFESCIENCES, LLC. | DETLOGIX ANNULOPLASTY RING, MODEL: 5100 | 04/10/2009 |
| K020864 | EDWARDS LIFESCIENCES, LLC. | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 | 04/17/2002 |
| K032250 | EDWARDS LIFESCIENCES, LLC. | GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 | 08/26/2003 |
| K230679 | Genesee Biomedical Inc | WellsForm Tricuspid Annuloplasty Band (WF) | 05/26/2023 |
| K190506 | Genesee BioMedical, Inc | NeoForm Annuloplasty Ring | 04/18/2019 |
| K202253 | Genesee BioMedical, Inc | TruForm Sievers Annuloplasty Ring | 10/06/2020 |
| K071214 | Genesee BioMedical, Inc. | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | 07/31/2007 |
| K090428 | Genesee BioMedical, Inc. | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | 05/07/2009 |
| K052899 | Genesee BioMedical, Inc. | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | 11/17/2005 |
| K052565 | Genesee BioMedical, Inc. | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | 11/17/2005 |
| K083683 | Genesee BioMedical, Inc. | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | 02/25/2009 |
| K072655 | Genesee BioMedical, Inc. | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | 10/23/2007 |
| K093903 | Genesee BioMedical, Inc. | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | 07/15/2010 |
| K161815 | Genesee BioMedical, Inc. | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | 10/12/2016 |
| K033685 | MEDICALCV, INC. | NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 | 08/03/2004 |
| K181132 | Medtronic | Tri-Ad 2.0 Adams Tricuspid Band | 05/29/2018 |
| K052860 | MEDTRONIC HEART VALVES | CG FUTURE ANNULOPLASTY BAND | 11/10/2005 |
| K032810 | MEDTRONIC HEART VALVES | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE | 12/05/2003 |
| K052970 | MEDTRONIC HEART VALVES | SIMPLICI-T ANNULOPLASTY SYSTEM | 01/11/2006 |
| K101212 | MEDTRONIC INC. | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | 08/07/2010 |
| K073324 | MEDTRONIC INC. | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R | 03/13/2008 |
| K061127 | MEDTRONIC VASCULAR | CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R | 05/23/2006 |
| K011395 | MEDTRONIC VASCULAR | MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B | 07/12/2001 |
| K984435 | MEDTRONIC VASCULAR | MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M | 01/07/1999 |
| K201449 | Medtronic, Inc. | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | 07/01/2020 |
| K070488 | MICARDIA CORPORATION | MICARDIA ANNULOPLASTY BAND DR | 09/04/2008 |
| K071281 | PETERS SURGICAL | UNIRING - ANNULOPLASTY RING WITH SIZERS | 08/03/2007 |
| K103812 | SCIENCITY CO., LTD | MITRA-LIFT | 05/18/2011 |
| K023940 | SHELHIGH, INC. | SHELHIGH BIORING | 06/04/2003 |
| K071327 | SORIN BIOMEDICA CARDIO S.R.L. | MEMO 3D SEMIRIGID ANNULOPLASTY RING | 08/10/2007 |
| K142221 | SORIN GROUP ITALIA S.R.L | MEMO 3D ReChord | 08/29/2014 |
| K180411 | Sorin Group Italia S.r.l. | MEMO 4D | 03/16/2018 |
| K083835 | ST. JUDE MEDICAL | ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR | 01/23/2009 |
| K092310 | ST. JUDE MEDICAL | SEGUIN ANNULOPLASTY RING | 08/27/2009 |
| K092876 | ST. JUDE MEDICAL | SJM ATTUNE ANNULOPLASTY RING | 10/16/2009 |
| K042734 | ST. JUDE MEDICAL, INC. | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) | 12/17/2004 |
| K014037 | ST. JUDE MEDICAL, INC. | SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) | 01/04/2002 |
| K961246 | ST. JUDE MEDICAL, INC. | SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M | 02/14/1997 |
| K022363 | ST. JUDE MEDICAL, INC. | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) | 09/19/2002 |
| K014161 | ST. JUDE MEDICAL, INC. | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) | 01/15/2002 |
| K000119 | ST. JUDE MEDICAL, INC. | SJM TAILOR ANNULOPLASTY RING, MODEL TARN | 02/17/2000 |
| K992056 | SULZER CARBOMEDICS, INC. | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 | 10/12/1999 |
| K023185 | SULZER CARBOMEDICS, INC. | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | 12/17/2002 |
| K021051 | SULZER CARBOMEDICS, INC. | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | 04/23/2002 |
| K980534 | THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG | DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H | 04/30/1998 |
| K960356 | THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG | POSTERIOR ANNULOPLASTY BAND (MODEL 607) | 08/27/1996 |
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