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Excelsior 1018 and Sl-10 Microcatheters

by Boston Scientific

510(k) K042568

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 · Special NumberK042568 Date15 Oct 2004ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0500-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0495-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0499-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0496-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0494-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0501-2014 FDA Class II initiated 4 Nov 2013
    • Terminated Z-0497-2014 FDA Class II initiated 4 Nov 2013

    Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

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  • Withdrawn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
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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