Modification to D-Tronplus

• • Terminated Z-1413-06 FDA Unclassified (pre-2012) ·initiated 13 Jul 2006

  The battery may turn the pump off without warning due to a design change in the battery.

• • Terminated Z-1105-05 FDA Unclassified (pre-2012) ·initiated 15 Jul 2005

  The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.

510(k) Number

K043000 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Disetronic Rapid Subcutaneous Infusion Set and Disteronic Rapid D Subcutaneous Infusion Set

  Class II

  FDA 510(k) K003977 Active Cleared 15 Feb 2001

• Modification to Disetronic D-Tronplus Insulin Infusion Pump

  Class II

  FDA 510(k) K022831 Active Cleared 11 Sep 2002

• Disetronic D-Modem

  Class II

  FDA 510(k) K943952 Active Cleared 7 Oct 1995

• Disetronic Pen

  Class II

  FDA 510(k) K982966 Active Cleared 19 Oct 1998

• Ultraflex Infusion Set

  Class II

  FDA 510(k) K033892 Active Cleared 9 Mar 2004

• Disetronic Multifuse Infusion Pump System

  Class II

  FDA 510(k) K001629 Active Cleared 21 Jun 2000

See all devices from Disetronic Medical Systems →