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Lead Introducer Set

by Introstat

510(k) K790882

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK790882 Date11 Jun 1979ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0280-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0283-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0277-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0273-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0279-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0281-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0274-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882
    • Terminated Z-0278-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006 on shared 510(k) K790882

    Catheter has separated from the infusion port body.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent