Stockert S5 System and Gas Blender and Sorin C5 System

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K101046 ↗

FDA Product Code

DTX

Device Class

Class II

Regulation

21 CFR Part 870.4300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• 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

See all devices from Sorin Group Deutschland GmbH →