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Bard Latex Urinary Catheters Drains- Designs Modif

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910846

by C. R. Bard, Inc.

Identifiers

510(k) Number
K910846 FDA 510(k)
FDA Product Code
EZC 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
SEKD FDA 510(k)

The Bard Latex Urinary Catheters Drains- Designs Modif is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. It is classified as a urological catheter and accessory, specifically a Coude catheter.

This device is manufactured by C.R. Bard, Inc. and received FDA 510(k) clearance on August 16, 1991. It is a Class II device under product code EZC with special controls. The device is available in various sizes and models as indicated by the multiple registration numbers associated with this clearance.

Frequently asked questions

What is the Bard Latex Urinary Catheter used for?

The Bard Latex Urinary Catheter is a flexible tubular device inserted through the urethra to pass fluids to or from the urinary tract. It is specifically designed as a Coude catheter for urological drainage procedures.

What sizes and models are available for this catheter?

The Bard Latex Urinary Catheter is available in various sizes and models, as indicated by the multiple registration numbers associated with this FDA clearance. The specific sizes and models would be detailed in the product catalog or packaging materials.

Is this a single-use or reusable catheter?

The device data does not specify whether this catheter is designed for single-use or reuse. This information would typically be found in the product's instructions for use or packaging materials provided by the manufacturer.

What is the regulatory status of this device?

The Bard Latex Urinary Catheter received FDA 510(k) clearance on August 16, 1991. It is classified as a Class II device under product code EZC with special controls, manufactured by C.R. Bard, Inc.

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 Latex Urinary Catheters Drains- Designs Modif (K910846) — Fda 510 ..., K910846 FDA 510(k) - BARD LATEX URINARY CATHETERS DRAINS- DE..., PDF K910846 - Bard Latex Urinary Catheters Drains- Designs Modif

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) K910846 24 fields · synced Sep 25, 2026