Data / Medical devices / Costa Rica / Edwards Lifesciences
Edwards Lifesciences: FDA-registered device maker in Guadalupe Cartago, Costa Rica, 9 510(k) clearances and 3 PMA approvals
Edwards Lifesciences is registered with the FDA (registration 3015287573) in Guadalupe Cartago, Costa Rica. It lists 5 device types. The FDA files 9 510(k) clearances and 3 PMA approvals under its listings, the newest dated September 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015287573
- Address
- Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts sur Finca 31 y 32, Guadalupe Cartago, Costa Rica, 30106
- Owner or operator
- Edwards Lifesciences LLC (9040666)
- Roles
- Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2027
- Brand names listed
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING, CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING, CARPENTIER-McCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING, Carpentier-Edwards Perimount Bioprosthesis, Carpentier-Edwards Physio Annuloplasty Ring, Carpentier-Edwards Physio Ring, Cosgrove-Edwards Annuloplasty Ring, EDWARDS MC3 TRICUSPID ANNULOPLASTY RING and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | 3 | Manufacturer | accessdata.fda.gov |
| Heart-Valve, Non-Allograft Tissue | LWR | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Mitral Valve, Percutaneously Delivered | NPU | 3 | Manufacturer | accessdata.fda.gov |
| Replacement Heart-Valve | DYE | 3 | Manufacturer | accessdata.fda.gov |
| Ring, Annuloplasty | KRH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2025 | K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 17, 2025 | K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 16, 2019 | K192762 | Physio Flex Annuloplasty Ring | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 24, 2011 | K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 15, 2009 | K083623 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 23, 2009 | K083470 | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 17, 2002 | K020864 | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 22, 1993 | K926138 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | KRH | Unknown | Baxter Healthcare Corp | accessdata.fda.gov |
| January 6, 1993 | K923367 | COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 | KRH | Unknown | Baxter Healthcare Corp | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 29, 2017 | P150048 | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) | LWR | 97 | October 22, 2026 | accessdata.fda.gov |
| June 17, 2015 | P140031 | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | NPT | 202 | October 22, 2026 | accessdata.fda.gov |
| September 26, 1991 | P860057 | EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES | DYE | 210 | July 29, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Ring, Annuloplasty
- All makers of Aortic Valve, Prosthesis, Percutaneously Delivered
- All makers of Prosthesis, Mitral Valve, Percutaneously Delivered
- All makers of Replacement Heart-Valve
- All makers of Heart-Valve, Non-Allograft Tissue
Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.