FDA 510(k) Applications Submitted by EDWARDS LIFESCIENCES, LLC.

FDA 510(k) Number Submission Date Device Name Applicant
K141495 06/06/2014 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER EDWARDS LIFESCIENCES, LLC.
K142749 09/24/2014 TruWave Disposable Pressure Transducer EDWARDS LIFESCIENCES, LLC.
K120780 03/14/2012 EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE EDWARDS LIFESCIENCES, LLC.
K102420 08/25/2010 EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA EDWARDS LIFESCIENCES, LLC.
K123298 10/23/2012 FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC.
K123303 10/23/2012 FEMORAL ACCESS VENOUS CANNULAE EDWARDS LIFESCIENCES, LLC.
K113411 11/18/2011 EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA EDWARDS LIFESCIENCES, LLC.
K113459 11/22/2011 ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC.
K082139 07/29/2008 EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 EDWARDS LIFESCIENCES, LLC.
K103520 11/30/2010 CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING EDWARDS LIFESCIENCES, LLC.
K031087 04/07/2003 EDWARDS INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC.
K032900 09/17/2003 LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS EDWARDS LIFESCIENCES, LLC.
K001734 06/07/2000 FOGARTY VALVULOTOME, MODEL 700091 EDWARDS LIFESCIENCES, LLC.
K053016 10/26/2005 WIRELESS PHYSIOLOGIC MONITORING SYSTEM EDWARDS LIFESCIENCES, LLC.
K053609 12/27/2005 PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC.
K041739 06/28/2004 EDWARDS E360 SURGICAL ABLATION DEVICE EDWARDS LIFESCIENCES, LLC.
K140241 01/30/2014 EDWARDS TRANSFEMORAL BALLOON CATHETER EDWARDS LIFESCIENCES, LLC.
K083470 11/24/2008 CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 EDWARDS LIFESCIENCES, LLC.
K083623 12/08/2008 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 EDWARDS LIFESCIENCES, LLC.
K060093 01/12/2006 PRESEP OLIGON OXIMETRY CATHETERS EDWARDS LIFESCIENCES, LLC.
K030944 03/26/2003 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC.
K091709 06/10/2009 MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC EDWARDS LIFESCIENCES, LLC.
K062134 07/26/2006 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC.
K082308 08/13/2008 MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC.
K033250 10/07/2003 EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR EDWARDS LIFESCIENCES, LLC.
K043065 11/05/2004 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P EDWARDS LIFESCIENCES, LLC.
K014054 12/10/2001 EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC.
K014052 12/10/2001 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC.
K093554 11/17/2009 RETROFLEX DILATOR KIT EDWARDS LIFESCIENCES, LLC.
K093877 12/16/2009 RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 EDWARDS LIFESCIENCES, LLC.
K031946 06/24/2003 EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE EDWARDS LIFESCIENCES, LLC.
K001565 05/19/2000 STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB EDWARDS LIFESCIENCES, LLC.
K120072 01/10/2012 VENOUS DRAINAGE CANNULA WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC.
K092509 08/17/2009 EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES, LLC.
K002578 08/18/2000 AXILLARY ACCESS ARTERIAL CANNULA EDWARDS LIFESCIENCES, LLC.
K123187 10/11/2012 RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA EDWARDS LIFESCIENCES, LLC.
K123370 11/01/2012 EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA EDWARDS LIFESCIENCES, LLC.
K113667 12/13/2011 CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC.
K024303 12/24/2002 EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC.
K060487 02/24/2006 LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC.
K030630 02/27/2003 EDWARDS DIRECTIONAL CATHETER EDWARDS LIFESCIENCES, LLC.
K050627 03/11/2005 LIFESTENT TURBO BILIARY STENT SYSTEMS EDWARDS LIFESCIENCES, LLC.
K061235 05/03/2006 LIFESTENT TURBO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC.
K052132 08/05/2005 MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC.
K052149 08/08/2005 EDWARDS PERIPHERAL DILATION CATHETER EDWARDS LIFESCIENCES, LLC.
K032587 08/22/2003 EDWARDS PERIPHERAL DILATATION CATHETER EDWARDS LIFESCIENCES, LLC.
K042985 10/29/2004 LIFESTENT NT35 BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC.
K053404 12/07/2005 LIFESTENT FLEXSTART BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC.
K140208 01/28/2014 FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII EDWARDS LIFESCIENCES, LLC.
K013990 12/03/2001 LIFESTITCH SUTURING DEVICE EDWARDS LIFESCIENCES, LLC.
K140398 02/18/2014 EMBOL-X INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC.
K131627 06/04/2013 CATHETER INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC.
K132175 07/15/2013 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC.
K123714 12/04/2012 EDWARDS EMBOL-X INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC.
K113565 12/02/2011 MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN EDWARDS LIFESCIENCES, LLC.
K110167 01/20/2011 PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) EDWARDS LIFESCIENCES, LLC.
K122381 08/06/2012 NEXFIN MODEL 2 EDWARDS LIFESCIENCES, LLC.
K103094 10/19/2010 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC.
K083191 10/29/2008 DETLOGIX ANNULOPLASTY RING, MODEL: 5100 EDWARDS LIFESCIENCES, LLC.
K152762 09/24/2015 Fogarty Occlusion Catheter EDWARDS LIFESCIENCES, LLC.
K150882 04/02/2015 Edwards Suture Fastening System EDWARDS LIFESCIENCES, LLC.
K100739 03/16/2010 VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 EDWARDS LIFESCIENCES, LLC.
K100709 03/12/2010 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M EDWARDS LIFESCIENCES, LLC.
K093911 12/22/2009 FOGARTY OCCLUSION CATHETER EDWARDS LIFESCIENCES, LLC.
K040287 02/06/2004 VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR EDWARDS LIFESCIENCES, LLC.
K060660 03/13/2006 EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER EDWARDS LIFESCIENCES, LLC.
K043103 11/09/2004 VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 EDWARDS LIFESCIENCES, LLC.
K140312 02/07/2014 EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM EDWARDS LIFESCIENCES, LLC.
K131588 05/31/2013 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC.
K131892 06/25/2013 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES, LLC.
K121185 04/18/2012 EDWARDS PERCUTANEOUS SHEATH INTRODUCER EDWARDS LIFESCIENCES, LLC.
K112694 09/15/2011 EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER EDWARDS LIFESCIENCES, LLC.
K113182 10/28/2011 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC.
K093730 12/03/2009 PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) EDWARDS LIFESCIENCES, LLC.
K020864 03/18/2002 EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 EDWARDS LIFESCIENCES, LLC.
K032250 07/22/2003 GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 EDWARDS LIFESCIENCES, LLC.


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