FDA Registration
Active
🇺🇸 United States
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated
Reg #: 2184009
·
FEI: 1000116158
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MEDTRONIC PERFUSION SYSTEMS
- Registration Number
- 2184009
- FEI Number
- 1000116158
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7611 Northland Dr
- City
- Minneapolis
- State
- MN
- ZIP
- 55428
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162958
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 |
|---|---|---|---|---|---|
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2017-03-03 |
Proprietary Names
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device