FDA Registration
Active
🇺🇸 United States
Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating
Reg #: 1825146
·
FEI: 1825146
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cook Incorporated
- Registration Number
- 1825146
- FEI Number
- 1825146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1100 W Morgan St
- City
- Spencer
- State
- IN
- ZIP
- 47460
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180182
Owner / Operator
- Firm Name
- COOK, INC.
- Operator Number
- 1820334
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2019-08-28 |
Proprietary Names
Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating
Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating
Dual Lumen Ureteral Access Catheter
Flexi-Tip® Dual Lumen Ureteral Access Catheter
Establishment Types
Manufacture Medical Device