Data / Medical devices / Mexico / Abbott Medical Mexico, S. de R.L. de C.V.
Abbott Medical Mexico, S. de R.L. de C.V.: FDA-registered device maker in Santa Rosa Jauregui Queretaro, Mexico, 2 510(k) clearances
Abbott Medical Mexico, S. de R.L. de C.V. is registered with the FDA (registration 3038966633) in Santa Rosa Jauregui Queretaro, Mexico. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038966633
- Address
- Avenida FINSA 156, Lote 12 Parque Industrial FINSA III, Santa Rosa Jauregui Queretaro, Mexico, C.P. 76223
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- July 1, 2025
- Registered through
- 2027
- Brand names listed
- Advisor HD Grid Sensor Enabled, High Density Mapping Catheter, Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter, Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer, Agilis NxT, Steerable Introducer, ViewFlex Eco, Reprocessed ICE Catheter, ViewFlex X ICE Catheter, Sensor Enabled, ViewFlex Xtra ICE Catheter, ViewFlex Xtra, ICE Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intracardiac Mapping, High-Density Array | MTD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | 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 |
|---|---|---|---|---|---|---|
| May 23, 2025 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 20, 2025 | K251231 | ViewFlex X ICE Catheter, Sensor Enabled | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Introducer, Catheter
- All makers of Reprocessed Intravascular Ultrasound Catheter
- All makers of Catheter, Intracardiac Mapping, High-Density Array
Updated May 23, 2025. 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.