EDWARDS LIFESCIENCES LLC

FDA Device Registration & Listing · IRVINE, CA, US · Registration 2015691

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2015691
FEI Number
2015691
Entity Name
EDWARDS LIFESCIENCES LLC
City/State/Country
IRVINE, CA, US
Establishment Address
ONE EDWARDS WAY, IRVINE, CA 92614, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Edwards Lifesciences LLC (Owner Number: 9040666)
Owner / Operator Contact Address
One Edwards Way, Irvine, CA 92614, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K140208
PMA Number
N/A

All Registered Proprietary Names

Edwards eSheath Optima introducer set Valve Placement Pack Minimally Invasive Suturing Instrument Knot Tying Instrument Valve Probe, Valve Seater, Knot Pusher Knot Pusher EMBOL-X AORTIC SIZERS Fogarty Thru-Lumen Embolectomy Catheter Carpentier-Edwards Perimount Bioprosthesis SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM TRAY, SURGICAL, INSTRUMENT Thruport Introducer Sheath Edwards eSheath+ introducer set PASCAL System - Table PASCAL System - Stabilizer Rail System Edwards Reusable Accessories - Reusable Platform Edwards Reusable Accessories - Reusable Cradle Edwards EVOQUE Accessories Edwards Reusable Rail Extension Edwards Reusable Accessories - Reusable Plate Edwards Stabilizer Rail System Edwards Stabilizer Set Edwards Rail Tray SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM Edwards Reusable Rail Edwards EVOQUE Stabilizer IntraClude Intra-Aortic Occlusion Device Axillary Access Arterial Cannulae Physio Flex Annuloplasty Ring PHYSIO FLEX Annuloplasty Ring INTRODUCER SHEATH KIT, 9 FR Intraclude Edwards EVOQUE Loading System and Trimmer Edwards EVOQUE EVOQUE tricuspid delivery system, dilator kit, and loading system Edwards EVOQUE valve EVOQUE CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING Ascendra Balloon Aortic Valvuloplasty Catheter Thruport Proplege Peripheral Retrograde Cardioplegia Device Edwards Pericardial Patch CARPENTIER-McCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING EDWARDS INTUITY Elite Valve System RetroFlex3 Introducer Sheath Set PASCAL Precision Transcatheter Valve Repair System JANKE-BARRON HEART SUPPORT Aortic Perfusion Cannulae Porous Vent plugs Femoral Venous Cannula Fem-Flex II Femoral Arterial Cannula FemTrak Femoral Venous Cannula Fem-Flex II Femoral Venous Cannula OptiSite Arterial Cannula Edwards Pericadial Patch Pediatric Peripheral access arterial cannulae Aortic Perfusion Cannulae Retrograde Cardioplegia Catheters Qualcrimp crimping accessory Edwards Crimper Edwards Expandable Introducer Sheath Set Edwards SAPIEN XT Transcatheter Heart Valve Ascendra+ System NovaFlex + Delivery System Crimp Stopper NovaFlex+ System Ascendra+ Delivery System Ascendra + Introducer Sheath Set Edwards Dilator Kit Edwards eSheath Optima introducer set CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING Cosgrove-Edwards Annuloplasty Ring Edwards Balloon Catheter-9350BC23 Edwards Balloon Catheter-9350BC20 Edwards Balloon Catheter-9350BC16 Edwards Balloon Catheter-9350BC25 Edwards Balloon Catheter EDWARDS MC3 TRICUSPID ANNULOPLASTY RING Arterial perfusion cannulae Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System Edwards Crimper Edwards Certitude Introducer Sheath Edwards Certitude Delivery System Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards eSheath Introducer Set- 914ES eSheath- 914ES Edwards eSheath Introducer Set- 916ES eSheath- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Vascular Tourniquet Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Crimper Edwards Commander Delivery System Edwards SAPIEN 3 Transcather Pulmonary Valve System with Alterra Adaptive Prestent Edwards SAPIEN 3 Pulmonic Delivery System Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System HEART VALVE SIZER Carpentier-Edwards Physio Annuloplasty Ring QuickDraw Venous Cannula Heart-Valve Holder Edwards Dilator Kit Miller Balloon Atrioseptostomy Fogarty Dilation Atrioseptostomy Venous Cannulae Femoral Access Arterial

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-04-18
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2001-05-18
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-09-18
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2024-09-18
DYE Replacement Heart-Valve Cardiovascular Class 3 870.3925 2008-01-17
NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown Class 3 N/A 2025-12-23
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1999-03-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-03-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-04-24
QWA Cardiovascular Delivery Catheter System Positioning And Stabilization Device Cardiovascular Class 1 870.3955 2023-05-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2017-02-16
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2007-12-17
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2019-12-23
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-11
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-11-22
NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown Class 3 N/A 2024-02-02
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2011-08-12
OZT Balloon Aortic Valvuloplasty Cardiovascular Class 2 870.1255 2014-11-18
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2012-09-06
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2012-12-18
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2009-09-24
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2016-08-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2010-10-14
NKM Mitral Valve Repair Devices Unknown Class 3 N/A 2022-09-15
MWS Stabilizer, Heart Cardiovascular Class 1 870.4500 2005-08-30
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-06-19
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2007-12-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2020-03-31
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2009-05-08
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2007-12-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2007-12-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-06-19
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2014-06-18
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2014-06-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-09-11
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2009-03-26
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-17
OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter Cardiovascular Class 2 870.1250 2016-02-05
OZT Balloon Aortic Valvuloplasty Cardiovascular Class 2 870.1255 2014-07-11
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-17
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2007-12-17
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2015-06-22
NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown Class 3 N/A 2015-06-22
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2009-05-08
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2020-09-10
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 1997-04-04
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2026-01-29
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2020-04-03
DTJ Holder, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3935 1997-04-04
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2010-06-08
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2022-09-01
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-03-17

Official Correspondent

Denny Kouri

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Edwards Lifesciences LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015179394 Edwards Lifesciences LTD Shannon Clare, IE
3017298588 Edwards Lifesciences Ireland Limited Limerick Munster, IE
3007063218 EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd Changi South East, SG
3015287573 Edwards Lifesciences Guadalupe Cartago, CR
3008500478 Edwards Lifesciences LLC Draper, UT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2010 Edwards Lifesciences, Llc N/A
Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.
Z-0013-2009 Edwards Lifesciences, LLC 2
Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2015691. Last updated year: 2026. Please use registration number 2015691 when referencing this establishment in official correspondence.
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