FDA Registration
Active
🇺🇸 United States
Abbott Medical
Reg #: 2648612
·
FEI: 2648612
·
Expires 2026
Products
4
Proprietary Names
23
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 2648612
- FEI Number
- 2648612
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 20 B Street, Caguas West Industrial Park
- City
- Caguas
- State
- PR
- ZIP
- 00725
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110193
- PMA Number
- P810002
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 |
|---|---|---|---|---|---|
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-09-20 |
| Ring, Annuloplasty | KRH | Class 2 | Cardiovascular | No | 2007-10-16 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-16 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2009-03-03 |
Proprietary Names
FemoStop II Plus
FemoStop Gold
SJM Tailor Annuloplasty Band
Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic)
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral)
Masters Series Mechanical Heart Valve (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral)
SJM Masters Series Mechanical Heart Valve
Masters Series Mechanical Heart Valve (Mitral)
Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic)
SJM Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)
Regent Mechanical Heart Valve
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Mitral)
Regent Mechanical Heart Valve (FlexCuff)
SJM Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff
Rigid Saddle Ring
SJM Rigid Saddle Ring
RadiStop
Seguin Annuloplasty Ring for Mitral Valve Repair
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device