Data / Medical devices / Dilator, Vessel, For Percutaneous Catheterization / Costa Rica
FDA-registered makers of Dilator, Vessel, For Percutaneous Catheterization in Costa Rica: 6 establishments
6 establishments in Costa Rica are registered with the FDA to make Dilator, Vessel, For Percutaneous Catheterization (product code DRE). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Dilator, Vessel, For Percutaneous Catheterization
- Product code
- DRE
- Country
- Costa Rica
Makers of Dilator, Vessel, For Percutaneous Catheterization in Costa Rica
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Theragenics Costa Rica Limitada | El Coyol Alajuela, Costa Rica | Manufacturer | 3 | September 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Cartago, Costa Rica | Manufacturer | 2 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 1 | June 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Theragenics Costa Rica Limitada | El Coyol, Alajuela, Costa Rica | Manufacturer | 1 | September 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health Costa Rica, S.A. | -- Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heraeus Medical Components, SRL | Guadalupe Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.