FDA Registration
Active
🇺🇸 United States
MEDTRONIC PERFUSION SYSTEMS
Reg #: 1718389
·
FEI: 1718389
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDTRONIC PERFUSION SYSTEMS
- Registration Number
- 1718389
- FEI Number
- 1718389
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18501 E Plaza Dr
- City
- PARKER
- State
- CO
- ZIP
- 80134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K894359
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 |
|---|---|---|---|---|---|
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2008-03-14 |
| Activated Whole Blood Clotting Time | JBP | Class 2 | Hematology | No | 2008-03-14 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2008-03-14 |
| Analyzer, Heparin, Automated | JOX | Class 2 | Hematology | No | 2008-03-14 |
| Timer, Clot, Automated | GKN | Class 2 | Hematology | No | 2008-03-14 |
| Protamine Sulphate | GFT | Class 2 | Hematology | No | 2008-03-14 |
Proprietary Names
CLOTtrac CWB
CLOTtrac HR Abnormal Control
LR-ACT
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
CLOTtrac
Heparin Assay 4 CH
ACT
ANALYZER, HEPARIN, AUTOMATED
CLOTtrac HTC
HMS Control
HEPtrac
Heparin Assay 6 CH
RACT Cartridge
Establishment Types
Manufacture Medical Device