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Glidesheath Slender

by Terumo Medical Corporation 2 variants

510(k) K142183

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 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 NumberK142183 Date21 Nov 2014ClearedStatusActive

Recalls

17 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-0218-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0227-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0226-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0230-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0219-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0216-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0221-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0225-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0222-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0228-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0217-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0223-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0229-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0224-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0220-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0214-2018 FDA Class II initiated 7 Jun 2017
    • Terminated Z-0215-2018 FDA Class II initiated 7 Jun 2017

    An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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