Angiomat Illumena

• • Terminated Z-2859-2011 FDA Unclassified (pre-2012) ·initiated 20 May 2011 ·on shared 510(k) K963071

  Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.

• • Terminated Z-0056-2008 FDA Unclassified (pre-2012) ·initiated 24 Aug 2007

  Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv

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

510(k) Number

K963071 ↗

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

• Optiv Antage Dh Power Injection System

  Class II

  FDA 510(k) K042744 Active Cleared 30 Nov 2004

• 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

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