FDA Registration
Active
🇺🇸 United States
VitalFlow Set with Balance Biosurface
Reg #: 3011468686
·
FEI: 3011468686
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MC3, Inc.
- Registration Number
- 3011468686
- FEI Number
- 3011468686
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2555 Bishop Circle West
- City
- Dexter
- State
- MI
- ZIP
- 48130
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240880
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 |
|---|---|---|---|---|---|
| Oxygenator, Long Term Support Greater Than 6 Hours | BYS | Class 2 | Cardiovascular | No | 2024-09-13 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2024-09-13 |
| Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | QJZ | Class 2 | Cardiovascular | No | 2024-09-13 |
| Tubing, Long Term Support Greater Than 6 Hours | QWF | Class 2 | Cardiovascular | No | 2024-09-13 |
Proprietary Names
VitalFlow Set with Balance Biosurface
Establishment Types
Manufacture Medical Device