Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015179394

FEI Number

3015179394

Entity Name

Edwards Lifesciences LTD

City/State/Country

Shannon Clare, IE

Establishment Address

10 Earhart Ave, Shannon Industrial Estates, Shannon Clare V14 P638, IE

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	Class 1	870.3955	2023-05-17

Official Correspondent

Denny Kouri

US Agent Details

Denny Kouri Business: EDWARDS LIFESCIENCES LLC Email: establishment_registration@edwards.com Phone: (949) 2502500

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
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
2015691	EDWARDS LIFESCIENCES LLC	IRVINE, CA, US

Similar Registrations

Registration Number	Establishment Name	Location
3017462098	POBA MEDICAL	Flagstaff, AZ, US
3007603855	KARDIUM Inc.	Burnaby British Columbia, CA
3017298588	Edwards Lifesciences Ireland Limited	Limerick Munster, IE
2015691	EDWARDS LIFESCIENCES LLC	IRVINE, CA, US
3005070406	Abbott Vascular	Menlo Park, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015179394. Last updated year: 2026. Please use registration number 3015179394 when referencing this establishment in official correspondence.