FDA Registration
Active
🇺🇸 United States
COMPACTCATH, INC
Reg #: 3011020307
·
FEI: 3011020307
·
Expires 2026
Products
7
Proprietary Names
2
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- COMPACTCATH, INC
- Registration Number
- 3011020307
- FEI Number
- 3011020307
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 887 Federation Way
- City
- Palo Alto
- State
- CA
- ZIP
- 94303
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160858
Owner / Operator
- Firm Name
- CompactCath, Inc
- Operator Number
- 10051743
- Address
- 887 Federation Way
- City
- Palo Alto
- State
- CA
- Postal Code
- 94303
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2022-11-16 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2019-12-16 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2026-04-13 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2016-04-28 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2021-02-01 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2018-06-20 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2022-11-16 |
Proprietary Names
CompactCath Drainage Bag, 2000ml
CompactCath Urinary Leg Bag, 500ml, 700ml, 1000ml
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility