FDA Registration
Active
🇮🇹 Italy
Quantum Perfusion Dual Lumen Cannula 27F
Reg #: 3016746283
·
FEI: 3016746283
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPECTRUM MEDICAL SRL
- Registration Number
- 3016746283
- FEI Number
- 3016746283
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via di Mezzo, 23
- City
- Mirandola Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K203067
Owner / Operator
- Firm Name
- Spectrum Medical SRL
- Operator Number
- 10069754
- Address
- Via di Mezzo, 23
- City
- Mirandola
- State
- Modena
- Postal Code
- 41037
- Country
- IT
- Correspondent
- Raffaella Tommasini
US Agent
- Business Name
- Spectrum Medical Inc.
- Contact Name
- Cameron Schmitt
- Address
- 481 Munn Road, Suite 180
- City
- Fort Mill
- State
- SC
- ZIP
- 29715
- Country
- US
- [email protected]
- Phone
- 803 8333964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2021-11-10 |
Proprietary Names
Quantum Perfusion Dual Lumen Cannula 27F
Quantum Perfusion Dual Lumen Cannula 31F
Quantum Perfusion Dual Lumen Cannula 24F
Quantum Perfusion Single Lumen Cannula 22F
Establishment Types
Manufacture Medical Device