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Disposable Coronary Control Syringe 12cc

by Merit Medical Systems, Inc.

510(k) K875196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 NumberK875196 Date11 Feb 1988ClearedStatusActive

Recalls

15 recalls · FDA

    • Terminated Z-1889-2017 FDA Class II initiated 23 Mar 2017 on shared 510(k) K875196

    Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip.

    • Terminated Z-1320-2014 FDA Class II initiated 13 Mar 2014 on shared 510(k) K875196

    The products are labeled as sterile but were not sterilized.

  • 6 recalls, same reason

    • Terminated Z-0061-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010 on shared 510(k) K875196
    • Terminated Z-0064-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010 on shared 510(k) K875196
    • Terminated Z-0063-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010 on shared 510(k) K875196
    • Terminated Z-0066-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010 on shared 510(k) K875196
    • Terminated Z-0065-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010 on shared 510(k) K875196
    • Terminated Z-0062-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010 on shared 510(k) K875196

    Small holes in the packaging may render the product non-sterile.

    • Terminated Z-0520-2010 FDA Unclassified (pre-2012) initiated 29 Sep 2009 on shared 510(k) K875196

    Potential sterility breach caused by excessive shipment damage.

  • 3 recalls, same reason

    • Terminated Z-2367-2008 FDA Unclassified (pre-2012) initiated 9 Jul 2008 on shared 510(k) K875196
    • Terminated Z-2368-2008 FDA Unclassified (pre-2012) initiated 9 Jul 2008 on shared 510(k) K875196
    • Terminated Z-2366-2008 FDA Unclassified (pre-2012) initiated 9 Jul 2008 on shared 510(k) K875196

    Control Syringes may be non-sterile due to holes in the packaging.

  • 2 recalls, same reason

    • Terminated Z-0048-05 FDA Unclassified (pre-2012) initiated 14 Sep 2004
    • Terminated Z-0049-05 FDA Unclassified (pre-2012) initiated 14 Sep 2004 on shared 510(k) K875196

    Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

    • Terminated Z-0912-03 FDA Unclassified (pre-2012) initiated 16 May 2003 on shared 510(k) K875196

    Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

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
DXT
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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