Vortex Access System

• • Terminated Z-0402-2011 FDA Unclassified (pre-2012) ·initiated 27 Sep 2010 ·on shared 510(k) K010189

  Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

• • Terminated Z-0149-2008 FDA Unclassified (pre-2012) ·initiated 3 Oct 2007

  Incorrect Size Catheter: The product may contain an incorrect size catheter.

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

510(k) Number

K010189 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Hmp Titanium Low Profile Port

  Class II

  FDA 510(k) K934573 Active Cleared 25 Feb 1994

• Triumph Vtx with Lifevalve Catheter

  Class II

  FDA 510(k) K032557 Active Cleared 9 Sep 2003

• Lifevalve Central Venous Cathter

  Class II

  FDA 510(k) K031718 Active Cleared 2 Jul 2003

• Hmp Dual Titanium Port

  Class II

  FDA 510(k) K934504 Active Cleared 25 Feb 1994

• Super C Hemodialysis/Apheresis Chronic Catheter, Model Dc-36 Series, Dc-40 Series, Dc-45 Series

  Class II

  FDA 510(k) K011916 Active Cleared 31 Oct 2001

• Hmp Titanium Port

  Class II

  FDA 510(k) K933990 Active Cleared 25 Feb 1994

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