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Gore Viatorr TIPS Endoprosthesis

by W. L. Gore & Associates, Inc.

PMA P040027510(k) K024178

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization 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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP040027 Date6 Dec 2004ApprovedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK024178 Date7 Mar 2003ClearedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Trade name
Gore Viatorr Tips
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
PMA number
510(k) Number
FDA product code
JCT
Device class
Class II
Regulation
21 CFR Part 878.3720
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Gore Viatorr TIPS Endoprosthesis is a portosystemic shunt designed to manage portal hypertension and its related clinical complications. It is indicated for use in both de novo and revision treatments for conditions including variceal bleeding, gastropathy, ascites, and hepatic hydrothorax.

This device is manufactured by W. L. Gore & Associates and has received FDA PMA and 510(k) authorizations. It is intended for clinical use in the treatment of specific hepatic conditions as defined by its regulatory indications.

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Questions

AI-generated answers, 18 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 Gore Viatorr TIPS Endoprosthesis used for?

    The device is indicated for the de novo and revision treatment of portal hypertension and its complications, which include variceal bleeding, gastropathy, ascites, and hepatic hydrothorax.

  • Who manufactures the Viatorr Endoprosthesis?

    The device is manufactured by W. L. Gore & Associates, Inc., based in Flagstaff, Arizona.

  • Is the Gore Viatorr TIPS Endoprosthesis FDA authorized?

    Yes, the device has received both FDA 510(k) and PMA authorizations for its indicated use in treating portal hypertension.