Edwards Lifesciences LLC

FDA Device Registration & Listing · Draper, UT, US · Registration 3008500478

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
3008500478
FEI Number
1713910
Entity Name
Edwards Lifesciences LLC
City/State/Country
Draper, UT, US
Establishment Address
12050 Lone Peak Parkway, Draper, UT 84020, US
Establishment Type(s)
Manufacture Medical Device
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
K852456
PMA Number
N/A

All Registered Proprietary Names

Internal Mammary Artery Cannulae Manual surgical instr., general use QuickDraw Venous Cannula Suction Wands and Sumps RetroFlex3 Introducer Sheath Set 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 IntraClude Intra-Aortic Occlusion Device Tapered carotid bypass shunts Thruport Endodirect Arterial Cannula Left Atrial Pressure Monitoring Catheter OptiSite Arterial Cannula Vent Catheters EMBOL-X ARTERIAL FILTER Cardioplegia delivery monitoring and infusion sets Thruport Intraclude Intra-Aortic Occlusion Device Thruport Introducer Sheath Thruport Endoclamp Aortic Catheters Intraclude Vascular Tourniquet Thruport Endodirect Arterial Cannula Arterial perfusion cannulae Axillary Access Arterial Cannulae Manual surgical instr. general use Valve Placement Pack Minimally Invasive Suturing Instrument Knot Tying Instrument Valve Probe, Valve Seater, Knot Pusher Knot Pusher EMBOL-X AORTIC SIZERS Anastaflo Intravascular Shunts Duraflo-treated femoral cannulae Antegrade Cardioplegia Cannula INTRODUCER SHEATH KIT, 9 FR Duraflo-Treated Suction Wands EMBOL-X ARTERIAL FILTER INTRODUCER SHEATH KIT,11 FR Edwards Balloon Catheter Single Stage Venous Drainage Cannula Cardioplegia Kits SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM Venous Cannulae Femoral Access Arterial PASCAL Precision Transcatheter Valve Repair System Edwards Balloon Catheter-9350BC23 Edwards Balloon Catheter-9350BC20 Edwards Balloon Catheter-9350BC16 Edwards Balloon Catheter-9350BC25 Port Access EV cardiopulmonary bypass system Femoral Access Arterial Cannula Femoral Venous Cannula Fem-Flex II Femoral Arterial Cannula FemTrak Femoral Venous Cannula Fem-Flex II Femoral Venous Cannula 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 Porous Vent plugs Vasoplegia cannulae Embol-X arterial cannulae Retrograde Cardioplegia Catheters Thruport Endoclamp Aortic Catheters Edwards eSheath+ introducer set Thruport Endovent Pulmonary Catheters Edwards EVOQUE Loading System and Trimmer Edwards EVOQUE EVOQUE tricuspid delivery system, dilator kit, and loading system Edwards EVOQUE valve EVOQUE EXIS EMBOL-X Introducer Sheath Aortic Perfusion Cannulae Ascendra Balloon Aortic Valvuloplasty Catheter Manual surgical instr. general use Physio Flex Annuloplasty Ring PHYSIO FLEX Annuloplasty Ring Thruport Endoclamp Aortic Catheters Pediatric Peripheral access arterial cannulae Aortic Perfusion Cannulae Thruport Proplege Peripheral Retrograde Cardioplegia Device VisuFlo Blower Thruport Endoplege Coronary Sinus Catheter Heart-Valve Holder HEART VALVE SIZER FAPCath Femoral arterial pressure monitoring catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2007-12-17
GAD Retractor General, Plastic Surgery Class 1 878.4800 2008-03-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2020-04-03
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2009-05-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2010-10-14
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2020-09-10
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
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2010-06-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2014-01-09
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2009-05-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2012-09-06
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2007-12-17
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2007-12-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-07-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-03-27
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-03-27
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-11-22
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2009-05-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-27
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2007-12-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2007-12-17
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2008-03-27
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2001-05-18
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 2010-11-01
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2012-09-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-11
DWD Suction Control, Intracardiac, Cardiopulmonary Bypass Cardiovascular Class 2 870.4430 2010-11-01
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2007-12-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-11
OZT Balloon Aortic Valvuloplasty Cardiovascular Class 2 870.1255 2014-07-11
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2012-09-06
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2007-12-17
NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown Class 3 N/A 2025-12-23
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2014-03-17
NKM Mitral Valve Repair Devices Unknown Class 3 N/A 2022-09-15
OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter Cardiovascular Class 2 870.1250 2016-02-05
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-03-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-11-21
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2020-03-31
QWA Cardiovascular Delivery Catheter System Positioning And Stabilization Device Cardiovascular Class 1 870.3955 2023-05-17
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 2007-12-17
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2011-08-29
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-06-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-03-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-04-24
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-27
NPW Percutaneously Delivered Prostheses And Tricuspid Valves Unknown Class 3 N/A 2024-02-02
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-12-10
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-06-19
OZT Balloon Aortic Valvuloplasty Cardiovascular Class 2 870.1255 2014-11-18
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 2008-03-27
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2019-12-23
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-03-27
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 2012-09-06
FQH Lavage, Jet General Hospital Class 2 880.5475 2009-05-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-03-27
DTJ Holder, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3935 1997-04-04
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 1997-04-04
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-01-13

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
2015691 EDWARDS LIFESCIENCES LLC IRVINE, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008500478. Last updated year: 2026. Please use registration number 3008500478 when referencing this establishment in official correspondence.
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