Modification to Vortex Mp Vascular Access Port

• • Ongoing Z-0132-2023 FDA Class II ·initiated 20 Sep 2022

  Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

• • Terminated Z-3071-2011 FDA Unclassified (pre-2012) ·initiated 30 Aug 2010

  The labeling contains errors which result in the products being misbranded

510(k) Number

K033473 ↗

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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