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 |