Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017298588

FEI Number

3017298588

Entity Name

Edwards Lifesciences Ireland Limited

City/State/Country

Limerick Munster, IE

Establishment Address

National Technology Park, Castletroy, Limerick Munster V94 31X5, 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

P200015

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 Edwards eSheath Introducer 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

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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-03-10
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered	Unknown	Class f	N/A	2020-09-10

Official Correspondent

Denny Kouri

US Agent Details

Denny Kouri Business: Edwards Lifesciences Email: Dennett_Kouri@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
3015179394	Edwards Lifesciences LTD	Shannon Clare, 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

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-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.

Similar Registrations

Registration Number	Establishment Name	Location
3017462098	POBA MEDICAL	Flagstaff, AZ, US
3015179394	Edwards Lifesciences LTD	Shannon Clare, IE
3007603855	KARDIUM Inc.	Burnaby British Columbia, CA
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 3017298588. Last updated year: 2026. Please use registration number 3017298588 when referencing this establishment in official correspondence.