Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022516937

FEI Number

3022516937

Entity Name

THE FLUME CATHETER COMPANY LTD

City/State/Country

Farnham Surrey, GB

Establishment Address

The Granary, Mill House, Frensham, Farnham Surrey GU10 3EE, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

The Flume Catheter Company Ltd (Owner Number: 10084981)

Owner / Operator Contact Address

The Granary, Mill House, Frensham, Farnham, GB-SRY GU10 3EE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231101

PMA Number

N/A

All Registered Proprietary Names

FLUME catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2023-10-18
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

Elaine Duncan Business: Paladin Medical Inc Email: duncan@paladinmedical.com Phone: (715) 5496035

Related Public Records

Same Entity

The Flume Catheter Company Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K132890	Mediplus , Ltd.	SUPRAPUBIC CATHETER AND INTRODUCER SET	2014-01-17
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022516937. Last updated year: 2026. Please use registration number 3022516937 when referencing this establishment in official correspondence.