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Avd Intimax (Tm) Biliary Catheter

by Applied Vascular

510(k) K910006

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK910006 Date13 Feb 1991ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2447-2012 FDA Class II initiated 9 Aug 2012

    Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 AVD INTIMAX BILIARY CATHETER is a device designed for use in the biliary ducts. It is classified as a stent, drain, or dilator for the biliary ducts and is intended for medical procedures involving these anatomical structures.

This device is supplied by Applied Vascular and has FDA 510(k) clearance with product code FGE. It is a Class II medical device and is not marked for single-use or reuse in the provided data. The device was cleared on February 13, 1991, and is regulated under 876.5010.

Other devices from Applied Vascular

Questions

AI-generated answers, 27 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 AVD INTIMAX Biliary Catheter used for?

    The AVD INTIMAX Biliary Catheter is designed for use in the biliary ducts as a stent, drain, or dilator during medical procedures involving these anatomical structures. It helps maintain bile flow and relieve obstructions in the biliary system.

  • Is the AVD INTIMAX Biliary Catheter single-use or reusable?

    The device is not specifically marked for single-use or reuse in the provided data. Users should consult the manufacturer's instructions for proper handling and sterilization protocols, as this information determines whether the device can be safely reused.

  • What regulatory approvals does the AVD INTIMAX Biliary Catheter have?

    The AVD INTIMAX Biliary Catheter has FDA 510(k) clearance with product code FGE. It is classified as a Class II medical device and is regulated under 876.5010. The device was cleared on February 13, 1991, and is considered substantially equivalent to predicate devices.

  • What sizes and models of the AVD INTIMAX Biliary Catheter are available?

    The provided data does not specify the available sizes or models of the AVD INTIMAX Biliary Catheter. Clinicians should contact Applied Vascular directly or consult the product documentation for detailed information regarding available configurations to ensure proper selection for specific clinical applications.

  • How should the AVD INTIMAX Biliary Catheter be stored?

    The storage requirements for the AVD INTIMAX Biliary Catheter are not specified in the provided data. Proper storage conditions are critical for maintaining device integrity, so users should refer to the manufacturer's instructions for specific storage recommendations, including temperature, humidity, and packaging requirements.