Data / Medical devices / United States / Compactcath, Inc
Compactcath, Inc: FDA-registered device maker in Palo Alto, CA, United States, 3 510(k) clearances
Compactcath, Inc is registered with the FDA (registration 3011020307) in Palo Alto, CA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011020307
- Address
- 887 Federation Way, Palo Alto, CA, United States, 94303
- Owner or operator
- CompactCath, Inc (10051743)
- Roles
- Specification developer
- First device listed
- April 28, 2016
- Registered through
- 2026
- Brand names listed
- CompactCath Drainage Bag, 2000ml, CompactCath Urinary Leg Bag, 500ml, 700ml, 1000ml
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Specification developer | accessdata.fda.gov |
| Catheter, Coude | EZC | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Urethral | GBM | 2 | Specification developer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Specification developer | accessdata.fda.gov |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | 1 | Specification developer | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2018 | K180738 | COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter | EZD | Substantially Equivalent | Compactcath, Inc. | accessdata.fda.gov |
| April 26, 2016 | K160858 | CompactCath Intermittent Urinary Catheter | EZD | Substantially Equivalent | Compactcath, Inc. | accessdata.fda.gov |
| February 13, 2012 | K111405 | BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, | GBM | Substantially Equivalent | Hangzhou Bever Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Coude
- All makers of Catheter, Straight
- All makers of Collector, Urine, Powered, Non Indwelling Catheter
- All makers of Collector, Urine, (And Accessories) For Indwelling Catheter
- All makers of Urinary Drainage Collection Kit, For Indwelling Catheter
- All makers of Catheter, Urethral
Updated June 14, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.