Data / Medical devices / Mexico / Baja Fur S.A. de C.V.
Baja Fur S.A. de C.V.: FDA-registered device maker in Tijuana Baja California, Mexico, 5 510(k) clearances
Baja Fur S.A. de C.V. is registered with the FDA (registration 3023209222) in Tijuana Baja California, Mexico. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023209222
- Address
- Calle Guerrero Negro 9965 Colonia Parque Industrial Pacifico Cuarta Etapa, Tijuana Baja California, Mexico, 22643
- Owner or operator
- VAPOTHERM, INC. (9038880)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 27, 2008
- Registered through
- 2026
- Brand names listed
- AAA-2, HVT 2, PF-ADPC-LOW, ProSoft Nasal Cannula
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| High Flow/High Velocity Humidified Oxygen Delivery Device | QAV | 2 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 13, 2026 | K254078 | HVT 2.0 | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| December 13, 2022 | K221318 | HVT 2.0 | QAV | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| October 28, 2022 | K220869 | Vapotherm Aerosol Adapter AAA-2 | CAF | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| August 25, 2021 | K203357 | HVT 2.0 | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
| July 17, 2008 | K072845 | PRECISION FLOW | BTT | Substantially Equivalent | Vapotherm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of High Flow/High Velocity Humidified Oxygen Delivery Device
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Cannula, Nasal, Oxygen
Updated April 13, 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.