FDA Registration
Active
🇺🇸 United States
MC3, Inc.
Reg #: 3011468686
·
FEI: 3011468686
·
Expires 2026
Products
10
Proprietary Names
26
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- MC3, Inc.
- Registration Number
- 3011468686
- FEI Number
- 3011468686
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2555 Bishop Circle West
- City
- Dexter
- State
- MI
- ZIP
- 48130
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132811
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 |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2024-04-21 |
| Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | QJZ | Class 2 | Cardiovascular | No | 2025-07-22 |
| Oxygenator, Long Term Support Greater Than 6 Hours | BYS | Class 2 | Cardiovascular | No | 2024-07-16 |
| Single Lumen Ecmo Cannula | QHW | Class 2 | Cardiovascular | No | 2026-02-13 |
| Dual Lumen Ecmo Cannula | PZS | Class 2 | Cardiovascular | No | 2024-04-21 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2024-07-16 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2024-04-21 |
| Tubing, Long Term Support Greater Than 6 Hours | QWF | Class 2 | Cardiovascular | No | 2024-09-13 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-12-21 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2003-06-24 |
Proprietary Names
Soft-Flow Extended Aortic Cannula
VitalFlow Set with Balance Biosurface-OUS
Nautilus VF ECMO Oxygenator
MC3 Nautilus Smart ECMO Module with Balance Biosuface
MC3 Nautilus ECMO Oxygenator with Balance Biosuface
Bio-Medicus Life Support Catheter and Introducer
Crescent Jugular Dual Lumen Catheter
Vitalflow Console
MC3 Vasular Access Kit
VitalFlow Set with Balance Biosurface
VitalFlow Console
VitalFlow Console-OUS
Power Cord Type F - CEE 7/7, 2.5 m-OUS
Power Cord Type L CEI 23-50, 2.5m-OUS
VitalFlow Motor Drive-OUS
VitalFlow Emergency Handcrank-OUS
Power Cord Type K AFSNIT 107-2-D1, 2.5m-OUS
Power Cord Type J SEV 1011, 2.5m-OUS
VitalFlow Flow and Bubble Sensor-OUS
Power Cord Type G BS1363/A, 2.5m-OUS
XPS Nexus
VitalFlow ECMO Cart
VitalFlow Centrifugal Pump
MC3 Nautilus Oxygenator Holder
Crescent RA Dual Lumen Catheter
Soft-Flow Aortic Cannula
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198