Data / Medical devices / Costa Rica / Theragenics Costa Rica Limitada
Theragenics Costa Rica Limitada: FDA-registered device maker in El Coyol Alajuela, Costa Rica, 6 510(k) clearances
Theragenics Costa Rica Limitada is registered with the FDA (registration 3011623145) in El Coyol Alajuela, Costa Rica. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 26, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011623145
- Address
- Zona Franca El Coyol, Building B 13.3, El Coyol Alajuela, Costa Rica, 20113
- Owner or operator
- Theragenics Corporation (1037598)
- Roles
- Manufacturer
- First device listed
- November 20, 2007
- Registered through
- 2026
- Brand names listed
- Coaxial, Dilator, Elite HV, Galt Medical Corp. Introducer Kits, GaltStick, Medcomp® BREEZE® AND BREEZE® XS INTRODUCER KIT, Micro-Access Tearaway, MicroSlide Tearaway Introducer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Percutaneous Sheath Introducer Kit | OFL | 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 |
| April 12, 2013 | K123430 | MICROSLIDER TEARAWAY INTRODUCER SET | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| October 31, 2007 | K071330 | GALTSTICK INTRODUCER SYSTEM | DRE | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| February 9, 2005 | K043525 | CATHETER INTRODUCER | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| August 1, 2000 | K000737 | COAXIAL DILATOR SET | DRE | Substantially Equivalent | Xentek Medical, Inc. | accessdata.fda.gov |
| June 16, 2000 | K000313 | TEARAWAY INTRODUCER SHEATH | DYB | Substantially Equivalent | Xentek Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Percutaneous Sheath Introducer Kit
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.