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Schneider Guider Softip Guiding Catheters

by Boston Scientific Scimed, Inc. 3 variants

510(k) K980453

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK980453 Date11 Aug 1998ClearedStatusActive

Recalls

20 recalls · 1 ongoing · FDA

    • Ongoing Z-1582-2022 FDA Class II initiated 9 Aug 2022

    The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

    • Terminated Z-2735-2018 FDA Class II initiated 11 Dec 2017

    Potential polymer material degradation.

  • 15 recalls, same reason

    • Terminated Z-0338-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0337-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0343-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0340-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0333-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0336-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0347-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0335-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0339-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0346-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0344-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0334-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0341-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0345-2017 FDA Class II initiated 5 Oct 2016
    • Terminated Z-0342-2017 FDA Class II initiated 5 Oct 2016

    Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.

    • Terminated Z-0107-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009

    Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.

    • Terminated Z-0259-2008 FDA Unclassified (pre-2012) initiated 11 Jul 2007

    Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)

    • Terminated Z-0260-2008 FDA Unclassified (pre-2012) initiated 11 Jul 2007

    Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)

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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