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Voyager Nc Coronary Dilatation Catheter and Nc Trek Rx Coronary Dilatation Catheter

by Abbott Vascular-Cardiac Therapies

510(k) K103153

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

20 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 NumberK103153 Date30 Dec 2010ClearedStatusActive

Recalls

20 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-1137-2020 FDA Class I initiated 29 Jan 2020
    • Terminated Z-1131-2020 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-1136-2020 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

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

  • 3 recalls, same reason

    • Terminated Z-2038-2017 FDA Class I initiated 22 Mar 2017
    • Terminated Z-2039-2017 FDA Class I initiated 22 Mar 2017
    • Terminated Z-2037-2017 FDA Class I initiated 22 Mar 2017

    Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating 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  • Withdrawn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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