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Bard E Luminexx Biliary Stent

by Bard Peripheral Vascular, Inc. 510(k)

Active United States

510(k) K063532

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK063532 Date30 May 2008ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

17 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-1464-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1459-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1466-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1456-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1469-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1462-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1467-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1455-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1454-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1468-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1458-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1460-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1457-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1463-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1461-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1453-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008
    • Terminated Z-1465-2009 FDA Unclassified (pre-2012) initiated 23 Dec 2008

    This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use".

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
SESU

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