FDA Registration
Active
🇮🇪 Ireland
Attain 6216A and 6218A Guide Catheters for Left Heart Delivery
Reg #: 9612164
·
FEI: 3002806434
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTRONIC IRELAND
- Registration Number
- 9612164
- FEI Number
- 3002806434
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PARKMORE BUSINESS PARK WEST
- City
- GALWAY
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K112917
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- Medtronic Vascular
- Contact Name
- GERARDINE FINN
- Address
- 3576 Unocal Place
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
- [email protected]
- Phone
- 707 5661548
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-03-13 |
Proprietary Names
Attain 6216A and 6218A Guide Catheters for Left Heart Delivery
Attain LDS 6216A Left Heart Delivery System
Attain Access 6218A Left Heart Delivery System
Establishment Types
Manufacture Medical Device