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Deseret Angio-Guide Large Vein Cath.

by Warner-Lambert Co.

510(k) K833092

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833092 Date21 Nov 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Deseret Angio-Guide Large Vein Cath. is a catheter device used for angiography procedures. It is designed to guide and facilitate access to large veins during medical imaging procedures.

This device is supplied by Warner-Lambert Co. and received FDA 510(k) clearance on November 21, 1983. It is classified under product code FOZ and was reviewed by the General Hospital advisory committee. The device is intended for single-use in clinical settings.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Deseret Angio-Guide Large Vein Catheter used for?

    The Deseret Angio-Guide Large Vein Catheter is designed to guide and facilitate access to large veins during angiography procedures, which are medical imaging techniques used to visualize blood vessels.

  • Is the Deseret Angio-Guide Large Vein Catheter reusable or single-use?

    This catheter is intended for single-use in clinical settings. It should not be reused on multiple patients as this could compromise sterility and increase infection risks.

  • What regulatory approvals does the Deseret Angio-Guide Large Vein Catheter have?

    The device received FDA 510(k) clearance on November 21, 1983, and is classified under product code FOZ. It was reviewed by the General Hospital advisory committee and determined to be substantially equivalent to predicate devices.

  • How is the Deseret Angio-Guide Large Vein Catheter supplied?

    The catheter is supplied by Warner-Lambert Co. and is designed for single-use in clinical settings. No specific packaging information is provided in the device data.