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ITI Stent

by Intratherapeutics, Inc.

510(k) K980290

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK980290 Date21 Jul 1998ClearedStatusActive

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1130-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1123-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1131-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1121-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1129-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1125-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1122-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1128-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1126-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1120-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1124-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008
    • Terminated Z-1127-2008 FDA Unclassified (pre-2012) initiated 18 Jan 2008

    Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

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  • Withdrawn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, 25 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 ITI Stent is a medical device categorized as a stent for the biliary ducts. It is indicated for use as a palliative treatment for malignant neoplasms in the biliary tree.

This device is regulated as a Class 2 medical device under FDA 510(k) clearance. It is designed for compression onto a delivery balloon catheter using manual techniques.

Other devices from Intratherapeutics, Inc.

See all devices from Intratherapeutics, Inc. →

Questions

AI-generated answers, 25 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 primary clinical use of the ITI Stent?

    The ITI Stent is indicated for use as a palliative treatment for patients diagnosed with malignant neoplasms located in the biliary tree.

  • How is the ITI Stent prepared for insertion?

    The device is designed to be compressed onto a delivery balloon catheter using manual techniques prior to placement in the biliary ducts.

  • What is the regulatory classification of this device?

    The ITI Stent is regulated as a Class 2 medical device and has received FDA 510(k) clearance under the product code FGE.