Modification to Stockert S5 System

• • Terminated Z-2073-2010 FDA Unclassified (pre-2012) ·initiated 18 Jun 2010

  Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.

510(k) Number

K062396 ↗

FDA Product Code

DTQ

Device Class

Class II

Regulation

21 CFR Part 870.4220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to: Stockert S5 System

  Class II

  FDA 510(k) K071318 Active Cleared 6 Jul 2007

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Connect

  Class II

  FDA 510(k) K170460 Active Cleared 8 Jun 2017

• Sorin Flextherm

  Class II

  FDA 510(k) K140012 Active Cleared 31 Jan 2014

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