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Bard LubriGuard Foley Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150699

by C. R. Bard, Inc.

Identifiers

510(k) Number
K150699 FDA 510(k)
FDA Product Code
EZL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard LubriGuard Foley Catheter is a synthetic polyisoprene device designed for the drainage, collection, and measurement of urine. It features a shaft with distal eyelets, an inflatable retention balloon, a drainage funnel, and an inflation arm equipped with a valve and cap.

This device is intended for single-use and is hydrogel-coated. It is authorized under FDA 510(k) clearance and is classified as a Class II medical device.

Frequently asked questions

What is the primary purpose of the Bard LubriGuard Foley Catheter?

This device is designed for the drainage, collection, and measurement of urine. It utilizes a shaft with distal eyelets and an inflatable retention balloon to facilitate these functions.

Is the Bard LubriGuard Foley Catheter intended for reuse?

No, this device is intended for single-use only. It is constructed from synthetic polyisoprene and features a hydrogel coating, which are designed for a single clinical application.

What are the key components of this catheter system?

The catheter includes a shaft with distal eyelets, an inflatable retention balloon for secure placement, a drainage funnel, and an inflation arm that features a valve and cap for balloon management.

What is the regulatory status of this device?

The Bard LubriGuard Foley Catheter is a Class II medical device that has received FDA 510(k) clearance. It is categorized under regulation number 876.5130.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bard LubriGuard Foley Catheter (K150699) — FDA 510 (k) | Innolitics, Foley Catheters - BD, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., C.R. Bard Inc — Class II recall: Products that contain the Pericare ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K150699 24 fields · synced Sep 23, 2026