FDA Registration
Active
🇲🇽 Mexico
Abbott Medical Mexico, S. de R.L. de C.V.
Reg #: 3038966633
·
FEI: 3038966633
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Abbott Medical Mexico, S. de R.L. de C.V.
- Registration Number
- 3038966633
- FEI Number
- 3038966633
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Avenida FINSA 156, Lote 12, Parque Industrial FINSA III
- City
- Santa Rosa Jauregui Queretaro
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K251231
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-09-04 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-07-01 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2025-07-01 |
Proprietary Names
ViewFlex Xtra ICE Catheter
ViewFlex X ICE Catheter, Sensor Enabled
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
Agilis NxT, Steerable Introducer
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
ViewFlex Xtra, ICE Catheter
Establishment Types
Manufacture Medical Device