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Nc Trek Rx Coronary Dilatation Catheter

by Abbott Vascular-Cardiac Therapies

510(k) K110134

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 NumberK110134 Date11 Feb 2011ClearedStatusActive

Recalls

17 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-1136-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1131-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1143-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1129-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1140-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1144-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1130-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1132-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1138-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1142-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1135-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1133-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1139-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1134-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1128-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1141-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1137-2020 FDA Class I initiated 29 Jan 2020

    Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

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  • Withdrawn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
LOX
Device Class
Class II
Regulation
21 CFR Part 870.5100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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