FDA Registration
Active
🇮🇪 Ireland
MEDTRONIC IRELAND
Reg #: 9612164
·
FEI: 3002806434
·
Expires 2026
Products
21
Proprietary Names
79
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- MEDTRONIC IRELAND
- Registration Number
- 9612164
- FEI Number
- 3002806434
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PARKMORE BUSINESS PARK WEST
- City
- GALWAY
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K143480
- PMA Number
- P200046
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 |
|---|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2015-04-07 |
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | Class f | Unknown | No | 2021-04-01 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2007-12-07 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2018-01-12 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2021-06-09 |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2010-12-22 |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | Class 3 | Unknown | No | 2014-12-30 |
| Leadless Pacemaker | PNJ | Class 3 | Cardiovascular | No | 2016-04-07 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2016-04-07 |
| Endovascular Suturing System | OTD | Class 2 | Cardiovascular | No | 2017-06-23 |
| Ablation Catheter, Renal Denervation | QYI | Class 3 | Unknown | No | 2023-11-18 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2017-04-28 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2015-08-13 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2014-01-17 |
| Agent, Occluding, Vascular, Permanent | PJQ | Class 3 | Unknown | No | 2017-12-14 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2012-01-01 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2025-06-24 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2023-11-27 |
| Drug-Coated Peripheral Transluminal Angioplasty Catheter | PRC | Class 3 | Unknown | No | 2019-11-21 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2023-12-15 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2024-10-25 |
Proprietary Names
Euphora Rapid Exchange Balloon Dilatation Catheter
Harmony Transcatheter Pulmonary Valve System
Reliant Stent Graft Balloon Catheter
Attain Select II 6248DEL
HawkOne Directional Atherectomy System
Telescope Guide Extension Catheter
TurboHawk Peripheral Plaque Excision System BTK (models SS-C, SS-CL, SX-C) Regulation Name: Intraluminal Artery Strippe
SELECTSITE
NC Euphora" Rapid Exchange Balloon Dilatation Catheter
Attain Select II + SureValve Delivery System
Attain Command + SureValve Delivery System
Sprinter Legend RX
Sprinter Over-the-Wire
NC Sprinter RX
NC Stormer Over-the-Wire
DiamondTemp Generator Connection Box E
DiamondTemp RF Generator
DiamondTemp EGM Cable
DiamondTemp GenConnect Cable
DiamondTemp Irrigation Tubing Set
DiamondTemp Ablation System
DiamondTemp Catheter-to-RF Generator Cable
DiamondTemp Irrigation Pump
DiamondTemp Ablation Catheter
DiamondTemp Foot Switch
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
TurboHawk Plus Directional Atherectomy System
Sprinter Legend 1.25 OTW
Sprinter Legend 1.25 RX
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
In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter
In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter
Attain Command + SureValve Left-Heart Delivery System
Attain Select II + SureValve Delivery Catheter System
Attain Command + SureValve Guide Catheter for Left-Heart Delivery
C315 Delivery Catheter
SelectSite C304-S59
SelectSite C304-XL74
SelectSite C304-L69
TurboHawk Peripheral Plaque Excision System
SilverHawk Peripheral Plaque Excision System
Micra Transcatheter Pacemaker System
Micra TPS
Micra AV TPS
Micra AV2 TPS
Micra VR2 TPS
SELECTSITE C304-HIS Deflectable catheter system
Heli-FX EndoAnchor System
Symplicity Spyral Renal Denervation System
Attain Command 6250
Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Onyx Frontier Zotarolimus-Eluting Coronary Stent System
Confida
CoreValve Evolut PRO System
Medtronic CoreValve System
CoreValve Evolut R System
CoreValve Evolut PRO+ System
Evolut FX+ System
Medtronic Evolut FX System
VenaSeal Closure System
ARES Antibiotic Impregnated Catheters
Liberant Thrombectomy System
Attain Command + SureValve Guide Catheters for Left Heart Delivery
Attain Command + SureValve Left Heart Delivery System
FlexCath Contour Steerable Sheath
Attain 6227DEF
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Attain Clarity 6225 Venogram Balloon Catheter
PulseSelect Pulsed Field Ablation (PFA)
Sphere-9 Catheter
Affera Ablation System
Attain Access 6218A Left Heart Delivery System
Attain 6216A and 6218A Guide Catheters for Left Heart Delivery
Attain LDS 6216A Left Heart Delivery System
Valiant Thoracic Stent Graft System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device