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LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE - Lifeshield Lf Macrobore Ext.

by Abbott Laboratories

510(k) K030002

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

29 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 NumberK030002 Date27 Jan 2003ClearedStatusActive

Recalls

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1385-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1362-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1386-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1335-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1374-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1334-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1363-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1375-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1372-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1332-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1348-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1371-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1365-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1369-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1376-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1370-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1368-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1361-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1380-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1367-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1347-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1379-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1366-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1373-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1328-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1381-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1346-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1378-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1377-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009

    Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

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
FPA
Models / Variants
Lifeshield Lf Macrobore Ext.
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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