FDA Registration
Active
🇺🇸 United States
Medtronic Vascular
Reg #: 2953200
·
FEI: 3001452571
·
Expires 2026
Products
10
Proprietary Names
19
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Medtronic Vascular
- Registration Number
- 2953200
- FEI Number
- 3001452571
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3576 Unocal Pl
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123990
- PMA Number
- P100040
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2011-04-12 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2017-04-28 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2013-05-03 |
| Endovascular Suturing System | OTD | Class 2 | Cardiovascular | No | 2018-11-26 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-12-20 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2015-04-10 |
| Ablation Catheter, Renal Denervation | QYI | Class 3 | Unknown | No | 2023-11-18 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2007-12-07 |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | Class 3 | Unknown | No | 2014-12-30 |
| Drug-Coated Peripheral Transluminal Angioplasty Catheter | PRC | Class 3 | Unknown | No | 2019-11-21 |
Proprietary Names
Valiant Thoracic Stent Graft System
Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Onyx Frontier Zotarolimus-Eluting Coronary Stent System
Sentrant Introducer Sheath
Heli-FX EndoAnchor System
Steerant Super Stiff Guidewire
Endurant II AUI Stent Graft System
Endurant Stent Graft System
Endurant IIs Stent Graft System
Endurant II Stent Graft System
Talent Occluder with Occluder Delivery System
Symplicity G3 Renal Denervation RF Generator Cart
Heli-FX Thoracic EndoAnchor System
Symplicity Spyral Renal Denervation System
Sentrant Introducer Sheath with Hydrophilic Coating
Reliant Stent Graft Balloon Catheter
In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter
In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility