Optiv Antage Dh Power Injection System

• • Terminated Z-0288-2007 FDA Unclassified (pre-2012) ·initiated 7 Nov 2006 ·on shared 510(k) K042744

  The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.

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

510(k) Number

K042744 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Optistar Elite Injection System

  Class II

  FDA 510(k) K073592 Active Cleared 7 May 2008

• Optivantage Dh Injector System with Enhanced Communication

  Class II

  FDA 510(k) K063503 Active Cleared 27 Apr 2007

• Optibolus

  Class II

  FDA 510(k) K031339 Active Cleared 11 Jul 2003

• Syringe with Handi-Fil

  Class II

  FDA 510(k) K082212 Active Cleared 22 Jan 2009

• Optistar MR Injector System

  Class II

  FDA 510(k) K984088 Active Cleared 6 Dec 1999

• Elph Injection System

  Class II

  FDA 510(k) K022116 Active Cleared 26 Jul 2002

See all devices from Mallinckrodt Inc., Liebel-Flarsheim Business →