FDA Registration
Active
🇺🇸 United States
CardioGard Emboli Protection Cannula
Reg #: 1836324
·
FEI: 3002998595
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Rose Medical
- Registration Number
- 1836324
- FEI Number
- 3002998595
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1440 Front Ave NW
- City
- Grand Rapids
- State
- MI
- ZIP
- 49504
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182302
Owner / Operator
- Firm Name
- Rose Medical
- Operator Number
- 10042209
- Address
- 1440 Front Avenue NW
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49504
- Country
- US
- Correspondent
- Eric Vroegop
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2019-06-07 |
Proprietary Names
CardioGard Emboli Protection Cannula
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)