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GT1 Floppy, GT1 Hi-per Flex, GT1 Light Support

by Arterial Vascular Engineering, Inc.

510(k) K983927

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK983927 Date11 Mar 1999ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0262-2014 FDA Class I initiated 21 Oct 2013
    • Terminated Z-0268-2014 FDA Class I initiated 21 Oct 2013

    Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

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  • Withdrawn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
DQT
Device Class
Class II
Regulation
21 CFR Part 870.1370
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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