FDA Registration
Active
🇺🇸 United States
HemoSphere
Reg #: 2648045
·
FEI: 2648045
·
Expires 2025
Products
8
Proprietary Names
4
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- EDWARDS LIFESCIENCES TECHNOLOGY SARL
- Registration Number
- 2648045
- FEI Number
- 2648045
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- STATE ROAD 402, KM 1.4, Industrial Park
- City
- ANASCO
- State
- PR
- ZIP
- 00610
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231248
Owner / Operator
- Firm Name
- Edwards Lifesciences LLC
- Operator Number
- 9040666
- Address
- One Edwards Way
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Denny Kouri
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2023-11-01 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2023-11-01 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2023-11-01 |
| Catheter, Oximeter, Fiber-Optic | DQE | Class 2 | Cardiovascular | No | 2023-11-01 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2023-11-01 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2023-11-01 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-11-01 |
| Adjunctive Predictive Cardiovascular Indicator | QAQ | Class 2 | Cardiovascular | No | 2023-11-01 |
Proprietary Names
HemoSphere
FloTrac Jr sensor
Swan-Ganz Jr catheter
ClearSight Jr finger cuff
Establishment Types
Manufacture Medical Device