Medrad Stellant CT Injector System

• • Terminated Z-0745-2019 FDA Class II ·initiated 14 Dec 2018

  If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

• • Terminated Z-0147-2012 FDA Unclassified (pre-2012) ·initiated 24 Oct 2011

  Packaging may exhibit open seals - sterility compromised

• • Terminated Z-1954-2010 FDA Unclassified (pre-2012) ·initiated 24 May 2010

  Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.

• • Terminated Z-0154-06 FDA Unclassified (pre-2012) ·initiated 10 Oct 2005

  the heat maintainer, an accessory, may overheat and deform the disposable syringe

• • Terminated Z-0257-05 FDA Unclassified (pre-2012) ·initiated 3 Nov 2004

  Sterility can be compromised by a tear in the outer packaging.

• • Terminated Z-0039-05 FDA Unclassified (pre-2012) ·initiated 8 Oct 2004

  Sterility can be compromised by a component tearing the outer packaging

510(k) Number

K023183 ↗

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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See all devices from Medrad, Inc. →