FDA Registration
Active
🇺🇸 United States
AccuTab
Reg #: 3011383638
·
FEI: 3011383638
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- POTRERO MEDICAL, INC.
- Registration Number
- 3011383638
- FEI Number
- 3011383638
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 26142 Eden Landing Road
- City
- Hayward
- State
- CA
- ZIP
- 94545
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221020
Owner / Operator
- Firm Name
- Potrero Medical, Inc.
- Operator Number
- 10050934
- Address
- 26142 Eden Landing Road
- City
- Hayward
- State
- CA
- Postal Code
- 94545
- Country
- US
- Correspondent
- Ron Chavez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2023-02-16 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2023-02-16 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-02-16 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2023-02-16 |
Proprietary Names
AccuTab
Accuryn SmartFoley UO Temp Tray System
Accuryn Monitoring System
Accuryn SmartFoley IAP UO Temp Tray System
Establishment Types
Manufacture Medical Device