Data / Medical devices / Costa Rica / Theragenics Costa Rica Limitada
Theragenics Costa Rica Limitada: FDA-registered device maker in El Coyol, Alajuela, Costa Rica, 2 510(k) clearances
Theragenics Costa Rica Limitada is registered with the FDA (registration 3036802499) in El Coyol, Alajuela, Costa Rica. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 26, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036802499
- Address
- Building B28, Module B, Zone Franca Coyol, El Coyol, Alajuela, Costa Rica, 20113
- Owner or operator
- Theragenics Corporation (1037598)
- Roles
- Manufacturer
- First device listed
- June 6, 2019
- Registered through
- 2026
- Brand names listed
- Dilator, GaltTWS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Stylet, Catheter | DRB | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 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 26, 2019 | K192195 | Sterile Dilator | DRE | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| May 30, 2019 | K182660 | GaltTWS | DRB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Wire, Guide, Catheter
- All makers of Stylet, Catheter
- All makers of Introducer, Catheter
- All makers of Dilator, Vessel, For Percutaneous Catheterization
Updated September 26, 2019. 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.