FDA Registration
Active
🇺🇸 United States
Abbott Vascular
Reg #: 3005070406
·
FEI: 3005070406
·
Expires 2026
Products
5
Proprietary Names
27
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Abbott Vascular
- Registration Number
- 3005070406
- FEI Number
- 3005070406
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3885 Bohannon Drive
- City
- Menlo Park
- State
- CA
- ZIP
- 94025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190167
- PMA Number
- P100009
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 |
|---|---|---|---|---|---|
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2024-11-14 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2019-07-17 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-02-07 |
| Tricuspid Valve Repair Device, Percutaneously Delivered | NPS | Class 3 | Unknown | No | 2024-09-26 |
| Mitral Valve Repair Devices | NKM | Class 3 | Unknown | No | 2013-11-22 |
Proprietary Names
MitraClip and TriClip Accessories Plate
MitraClip and TriClip Accessories Stabilizer
MitraClip and TriClip Accessories Lift
Steerable Guide Catheter
TriClip G5 Steerable Guide Catheter
MitraClip G5 Steerable Guide Catheter
TriClip G4 Clip Delivery System
TriClip G5 Delivery System
TriClip XTR Clip Delivery System
TriClip NTR Clip Delivery System
MitraClip Clip Delivery System
MitraClip G4 System
MitraClip G5 Delivery system
MitraClip G4 SCG
TriClip Steerable Guide Catheter
CPS Direct PL
CPS Direct PL VBT
Renal Guide Catheter
MitraClip Steerable Guide Catheter
MitraClip G4 Steerable Guide Catheter
MitraClip NTR Clip Delivery System
MitraClip G4 Clip Delivery System
MitraClip XTR Clip Delivery System
MitraClip G5 Delivery System
TriClip G4 System
TriClip G4 Delivery System
TriClip G5 Delivery system
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only