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Intravascular Administration Set

by Multi-Med, Inc. 4 variants

510(k) K891919

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

75 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 NumberK891919 Date5 May 1989ClearedStatusActive

Recalls

75 recalls · FDA

  • 73 recalls, same reason

    • Terminated Z-2558-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2510-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2522-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2525-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2577-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2566-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2521-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2544-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2550-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2578-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2540-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2565-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2571-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2507-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2515-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2576-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2514-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2509-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2549-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2530-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2575-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2536-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2534-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2518-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2564-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2548-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2572-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2569-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2539-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2506-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2557-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2553-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2547-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2542-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2560-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2562-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2508-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2524-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2568-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2563-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2546-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2570-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2512-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2527-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2520-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2567-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2533-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2561-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2523-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2532-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2519-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2531-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2511-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2513-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2526-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2552-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2559-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2529-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2555-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2541-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2537-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2554-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2551-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2535-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2543-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2517-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2573-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2574-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2538-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2545-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2528-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2516-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010
    • Terminated Z-2556-2010 FDA Unclassified (pre-2012) initiated 30 Aug 2010

    Huber needles may core and result in port leakage or emboli being flushed our of the port.

  • 2 recalls, same reason

    • Terminated Z-1889-2010 FDA Unclassified (pre-2012) initiated 26 May 2010
    • Terminated Z-1888-2010 FDA Unclassified (pre-2012) initiated 26 May 2010

    FDA sample determined the needles to be coring.

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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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