Edwards Lifesciences

FDA Device Registration & Listing · Guadalupe Cartago, CR · Registration 3015287573

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
3015287573
FEI Number
3015287573
Entity Name
Edwards Lifesciences
City/State/Country
Guadalupe Cartago, CR
Establishment Address
Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts sur, Finca 31 y 32, Guadalupe Cartago 30106, CR
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
N
Expiration Date (Year)
2026
510(k) Number
K926138
PMA Number
N/A

All Registered Proprietary Names

INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis KONECT RESILIA Aortic Valved Conduit MITRIS RESILIA Mitral Valve TRIFORMIS RESILIA Tricuspid Valve EDWARDS MC3 TRICUSPID ANNULOPLASTY RING 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 Physio Flex Annuloplasty Ring PHYSIO FLEX Annuloplasty Ring Edwards MC3 Tricuspid Annuloplasty Ring Carpentier-Edwards Perimount Bioprosthesis CARPENTIER-McCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING Cosgrove-Edwards Annuloplasty Ring CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING Carpentier-Edwards Physio Annuloplasty Ring Carpentier-Edwards Physio Ring

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2017-07-11
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 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
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2019-12-23
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2026-01-29
DYE Replacement Heart-Valve Cardiovascular Class 3 870.3925 2008-01-17
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2009-09-24
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-17
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2009-03-26
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2026-01-29
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-12-17

Official Correspondent

Denny Kouri

US Agent Details

DENNY KOURI 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
3017298588 Edwards Lifesciences Ireland Limited Limerick Munster, IE
3007063218 EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd Changi South East, SG
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
K253232 ABBOTT MEDICAL Seguin Annuloplasty Ring 2025-10-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0491-2025 Abbott Medical 3
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025 Abbott Medical 3
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Z-0494-2025 Abbott Medical 3
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Z-0495-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Similar Registrations

Registration Number Establishment Name Location
3010432890 Sterigenics Costa Rica S.R.L. El Coyol Alajuela, CR
2135147 Abbott Medical Plymouth, MN, US
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR
3007113487 Abbott Medical Saint Paul, MN, US
3007063218 EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd Changi South East, SG
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015287573. Last updated year: 2026. Please use registration number 3015287573 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.