510(k) K060053 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
STOCKERT S5 SYSTEM
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jun 2, 2006 |
| Received | Jan 6, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2012 | Sorin Group USA, Inc. Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 System i Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 Sy Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 800 Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 8000 Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST ROLLER PUMP, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-00
The S5 System is used to perform, con Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PUMPS, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-60
The S5 System is used to perform Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUMPS 85 W/ COUPLING, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-62
The S5 System is used to per Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROLLER PUMP 85, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-70
The S5 System is used to perform, Terminated |
DTQ | None listed |
| Mar 5, 2012 | Sorin Group USA, Inc. SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA
The S5 System is used to Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used to perform, con Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used to perfor Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany.
Used to perform, control and monitor extracorporeal blood circulation during an Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used to perform, co Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004.
Used Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004.
Used to perform, control and monitor extracorporeal bl Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. 2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004.
Used to perform, control and monitor extraco Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004.
Used to perform, control and monitor extracorporeal blo Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004.
Used to perform, control and monitor ext Terminated |
DTQ | None listed |
| Jan 26, 2011 | Sorin Group USA, Inc. SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.