FDA Registration
Active
🇮🇹 Italy
INSPIRE 7F M oxgenator with integrated arterial filter
Reg #: 9680841
·
FEI: 3005426550
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SORIN GROUP ITALIA S.R.L
- Registration Number
- 9680841
- FEI Number
- 3005426550
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 86, VIA STATALE 12 NORD
- City
- MIRANDOLA Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K200683
Owner / Operator
- Firm Name
- SORIN GROUP ITALIA S.R.L
- Operator Number
- 9011842
- Address
- 86, VIA STATALE 12 NORD, --
- City
- MIRANDOLA (MO)
- State
- Modena
- Postal Code
- 41037
- Country
- IT
- Correspondent
- LUIGI - VECCHI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | Class 2 | Cardiovascular | No | 2020-06-16 |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | Class 2 | Cardiovascular | No | 2020-06-16 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2020-06-16 |
| Defoamer, Cardiopulmonary Bypass | DTP | Class 2 | Cardiovascular | No | 2020-06-16 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2020-06-16 |
Proprietary Names
INSPIRE 7F M oxgenator with integrated arterial filter
INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
Establishment Types
Manufacture Medical Device