FDA Registration
Active
🇮🇪 Ireland
ABBOTT VASCULAR
Reg #: 3005718570
·
FEI: 3005718570
·
Expires 2026
Products
8
Proprietary Names
21
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- ABBOTT VASCULAR
- Registration Number
- 3005718570
- FEI Number
- 3005718570
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CASHEL ROAD
- City
- CLONMEL Tipperary
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K252512
- PMA Number
- P050007
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
US Agent
- Business Name
- Abbott Vascular
- Contact Name
- Keith Krohn
- Address
- 26531 Ynez Road, M/S TCC-215
- City
- Temecula
- State
- CA
- ZIP
- 92591
- Country
- US
- [email protected]
- Phone
- 951 9143324
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2007-11-19 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2026-03-12 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2006-05-05 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2011-01-03 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2007-11-26 |
| Coronary Covered Stent | NIV | Class f | Unknown | No | 2007-11-26 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2011-11-01 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2012-08-01 |
Proprietary Names
StarClose SE Vascular Closure System
Armada 14 NC PTA Catheter
Armada 18 PTA Catheter
Multi-Link Mini Vision
Multi-Link Vision-
MULTI-LINK 8 Stent System
Multi-Link 8-
Armada 14 PTA Catheter
Graftmaster
Graftmaster RX
ProGlide
Perclose AT
Prostar XL 10 F
Perclose ProStyle Suture-Mediated Closue and Repair System
XIENCE Alpine Everolimus Eluting Stent System
XIENCE Xpedition Everolimus Eluting Stent System
XIENCE Sierra Everolimus Eluting Stent System
XIENCE Skypoint Everolimus Eluting Stent System
XIENCE PRIME Everolimus Eluting Stent System
XIENCE ProS Everolimus Eluting Stent System
Omnilink Elite
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device