Data / Medical devices / United Kingdom / The Flume Catheter Company Ltd
The Flume Catheter Company Ltd: FDA-registered device maker in Farnham Surrey, United Kingdom, 1 510(k) clearance
The Flume Catheter Company Ltd is registered with the FDA (registration 3022516937) in Farnham Surrey, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022516937
- Address
- The Granary, Mill House Frensham, Farnham Surrey, United Kingdom, GU10 3EE
- Owner or operator
- The Flume Catheter Company Ltd (10084981)
- Roles
- Specification developer
- First device listed
- October 18, 2023
- Registered through
- 2026
- Brand names listed
- FLUME catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Suprapubic (And Accessories) | KOB | 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 29, 2023 | K231101 | Flume Catheter | EZL | Substantially Equivalent | Flume Catheter Company, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 29, 2023. 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.