Port-A-Cath Power P.A.C. Implantable Venous Access Systems

• • Terminated Z-1074-2018 FDA Class II ·initiated 4 Dec 2017

  Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.

510(k) Number

K093414 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket

  Class II

  FDA 510(k) K061513 Active Cleared 1 Aug 2006

• SAF-T Closed Blood Collection System with SAF-Holder Device, Model 99200

  Class II

  FDA 510(k) K072783 Active Cleared 30 Nov 2007

• Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits

  Class II

  FDA 510(k) K071958 Active Cleared 21 Nov 2007

• Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012

  Class II

  FDA 510(k) K092256 Active Cleared 20 Oct 2010

• EchoGlo Needle

  Class II

  FDA 510(k) K171968 Active Cleared 25 Jan 2018

• Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes

  Class II

  FDA 510(k) K081440 Active Cleared 12 Sep 2008

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