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Vascon Neuropath Guiding Catheter

by Vascon, LLC

510(k) K052004

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

24 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 NumberK052004 Date19 Jan 2006ClearedStatusActive

Recalls

24 recalls · FDA

  • 23 recalls, same reason

    • Terminated Z-0865-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0861-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0847-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0856-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0848-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0854-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0846-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0852-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0849-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0844-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0858-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0859-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0863-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0862-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0850-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0855-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0851-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0857-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0843-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0845-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0860-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0853-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-0864-2013 FDA Class II initiated 11 Jan 2013

    Sterility of device may be compromised due to lack of package integrity

    • Terminated Z-0842-2013 FDA Class II initiated 11 Jan 2013

    Sterility of device may be compromised due to lack of packaging 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  • Withdrawn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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