Data / Medical devices / Dominican Republic / Oscor Caribe LLC
Oscor Caribe LLC: FDA-registered device maker in SANTO DOMINGO Distrito Nacional, Dominican Republic, 1 510(k) clearance
Oscor Caribe LLC is registered with the FDA (registration 3004785273) in SANTO DOMINGO Distrito Nacional, Dominican Republic. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2015. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004785273
- Address
- Zona Franca Las Americas Nave A1-2, SANTO DOMINGO Distrito Nacional, Dominican Republic, --
- Owner or operator
- OSCOR CARIBE LLC (9068575)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- March 7, 2008
- Registered through
- 2026
- Brand names listed
- Adelante, Adelante Adelante-S, SafeSheath Ultra with VBT, Adelante Breezeway Delivery Sheath, Adelante Destino, Adelante Destino Steerable Guiding Sheath, Adelante Radial, Adelante Sigma, Adelante Sigma AT, Adelante Targa and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Pacemaker Lead Adaptor | DTD | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Contract manufacturer, Contract sterilizer | 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 22, 2015 | K151951 | Destino Reach | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Introducer, Catheter
- All makers of Electrode, Pacemaker, Temporary
- All makers of Pacemaker Lead Adaptor
- All makers of Probe, Radiofrequency Lesion
Updated September 22, 2015. 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.