FDA Registration
Active
🇨🇭 Switzerland
CentriMag Blood Pump, CentriMag Acute Circulatory Support System
Reg #: 3003306248
·
FEI: 3003306248
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Thoratec Switzerland GMBH
- Registration Number
- 3003306248
- FEI Number
- 3003306248
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- TECHNOPARKSTRASSE 1
- City
- ZURICH
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K222038
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- ABBOTT LABORATORIES
- Contact Name
- Lucy Tan
- Address
- 6035 Stoneridge Drive
- City
- Pleasanton
- State
- CA
- ZIP
- 94588
- Country
- US
- [email protected]
- Phone
- 925 4169778
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2023-01-18 |
Proprietary Names
CentriMag Blood Pump, CentriMag Acute Circulatory Support System
Establishment Types
Manufacture Medical Device