FDA Registration
Active
🇺🇸 United States
CIRCUIT TUBINGS WITH X-COATING
Reg #: 1124841
·
FEI: 3000204839
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Registration Number
- 1124841
- FEI Number
- 3000204839
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 125 BLUE BALL RD
- City
- ELKTON
- State
- MD
- ZIP
- 21921
- Country
- US
Regulatory Submissions
- 510(k) Number
- K023056
Owner / Operator
- Firm Name
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Operator Number
- 1828100
- Address
- 6200 Jackson Road, --
- City
- Ann Arbor
- State
- MI
- Postal Code
- 48103
- Country
- US
- Correspondent
- Lisa G Hessabi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2022-11-07 |
Proprietary Names
CIRCUIT TUBINGS WITH X-COATING
Establishment Types
Manufacture Medical Device