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Stent Support Guide Catheter

by Medtronic Vascular

510(k) K010579

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

27 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 NumberK010579 Date21 Nov 2001ClearedStatusActive

Recalls

27 recalls · FDA

    • Terminated Z-2754-2011 FDA Unclassified (pre-2012) initiated 8 Jun 2011

    Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve

  • 26 recalls, same reason

    • Terminated Z-1032-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1029-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1022-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1030-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1031-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1027-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1017-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1037-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1015-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1033-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1036-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1039-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1038-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1016-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1024-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1014-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1020-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1023-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1021-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1035-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1025-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1026-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1028-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1040-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1034-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006
    • Terminated Z-1018-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006

    Potential for non-sterility due to loss of package integrity

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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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