Company ยท US
Sorin Group Deutschland GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2017. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 15 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 6 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 |
| DXJ | Display, Cathode-Ray Tube, Medical | 2 |
| CAC | Apparatus, Autotransfusion | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 8, 2017 | K170460 | Sorin Connect Sorin Group Deutschland GmbH, DE | DXJ |
| Mar 21, 2014 | K131553 | XTRA Sorin Group Deutschland GmbH | CAC |
| Jan 31, 2014 | K140012 | SORIN FLEXTHERM Sorin Group Deutschland GmbH | DWC |
| Jul 23, 2013 | K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM Sorin Group Deutschland GmbH, DE | DXJ |
| Sep 20, 2011 | K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) Sorin Group Deutschland GmbH | DWA |
| Jan 20, 2011 | K103762 | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE Sorin Group Deutschland GmbH | DTQ |
| Jan 20, 2011 | K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) Sorin Group Deutschland GmbH | DWA |
| Jan 18, 2011 | K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 Sorin Group Deutschland GmbH | KRL |
| Jan 6, 2011 | K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) Sorin Group Deutschland GmbH | DRY |
| Dec 9, 2010 | K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM Sorin Group Deutschland GmbH | DTX |
| Jan 15, 2010 | K093882 | SORIN C5 SYSTEM MODEL 58-00-00 Sorin Group Deutschland GmbH | DTQ |
| Nov 5, 2009 | K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH | DTQ |
| Jul 15, 2009 | K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 Sorin Group Deutschland GmbH | DWA |
| Jul 2, 2009 | K091007 | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 Sorin Group Deutschland GmbH | DTQ |
| Dec 17, 2008 | K082344 | STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) Sorin Group Deutschland GmbH | DWF |
| Jul 30, 2008 | K080832 | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER Sorin Group Deutschland GmbH | DTQ |
| Jul 6, 2007 | K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH | DTQ |
| Sep 28, 2006 | K062396 | MODIFICATION TO STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH | DTQ |
| Jun 6, 2006 | K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH | DWC |
| Jun 2, 2006 | K060053 | STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH | DTQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2017 | Sorin Group Deutschland GmbH CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor. Terminated |
DWA | K112225 |
| Jan 28, 2014 | Sorin Group Deutschland GmbH CP5 centrifugal pump system
Product Usage:
The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Terminated |
DWA | K112225 |
| Jan 28, 2014 | Sorin Group Deutschland GmbH S5/C5 Heart-lung machine
Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Terminated |
DTQ | K071318 K093882 |
| Nov 4, 2013 | Sorin Group Deutschland GmbH S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00.
The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Sorin C5 (perfusion system)
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K093882 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Pump control panel.
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DWA | K112225 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Control panel for mast roller pump 85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Control panel for mast roller pump 150/85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH S5 Double Roller Pump 85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |
| Mar 29, 2012 | Sorin Group Deutschland GmbH S5 Single Roller Pump 150
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | K071318 |