Data / Medical devices / Germany / LivaNova Deutschland GmbH
LivaNova Deutschland GmbH: FDA-registered device maker in MUNCHEN Bavaria, Germany, 28 510(k) clearances
LivaNova Deutschland GmbH is registered with the FDA (registration 9611109) in MUNCHEN Bavaria, Germany. It lists 11 device types. The FDA files 28 510(k) clearances under its listings, the newest dated August 24, 2023. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611109
- FEI number
- 3002808267
- Address
- Lindbergh Strasse 25, MUNCHEN Bavaria, Germany, 80939
- Owner or operator
- LivaNova Deutschland GmbH (8010598)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 10, 2000
- Registered through
- 2026
- Brand names listed
- AC Outlet with Isolation Transformer for C5, AC Outlet with Isolation Transformer for S5, B-Capta, Connect Manager: server application to store, manage and display data from DMS recorder in the hospital environment, Connect Reorder: online perfusion assistant inside OR embedded into a medical PC, ESSENZ Patient Monitor, Essenz HLM, Essenz ILBM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Autotransfusion | CAC | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | 2 | Manufacturer | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Manufacturer | accessdata.fda.gov |
| Controller, Temperature, Cardiopulmonary Bypass | DWC | 2 | Specification developer | accessdata.fda.gov |
| Detector, Bubble, Cardiopulmonary Bypass | KRL | 2 | Manufacturer | accessdata.fda.gov |
| Display, Cathode-Ray Tube, Medical | DXJ | 2 | Manufacturer | accessdata.fda.gov |
| Gas Control Unit, Cardiopulmonary Bypass | DTX | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | 2 | Manufacturer | accessdata.fda.gov |
| NSX | NSX | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 24, 2023 | K232291 | Essenz HLM, Essenz ILBM | DTQ | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| March 9, 2023 | K221373 | Essenz HLM | DTQ | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| November 16, 2022 | K220635 | Heater-Cooler System 3T | DWC | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| November 10, 2021 | K212003 | ESSENZ Patient Monitor | DXJ | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| April 5, 2021 | K210130 | Stockert S5 System | DTQ | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| April 1, 2021 | K202154 | B-Capta | DRY | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| February 25, 2020 | K191402 | Heater-Cooler System 3T | DWC | Substantially Equivalent | Livanova Deutschland, GmbH | accessdata.fda.gov |
| June 8, 2017 | K170460 | Sorin Connect | DXJ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| March 21, 2014 | K131553 | XTRA | CAC | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| July 23, 2013 | K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | DXJ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| September 20, 2011 | K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | DWA | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| September 6, 2011 | K112245 | XTRA | CAC | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| April 7, 2011 | K110782 | XVAC | CAC | Substantially Equivalent | Sorin Group Italia S.R.L. | accessdata.fda.gov |
| January 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 | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| January 18, 2011 | K103469 | STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 | KRL | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| January 6, 2011 | K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | DRY | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| December 9, 2010 | K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | DTX | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| January 15, 2010 | K093882 | SORIN C5 SYSTEM MODEL 58-00-00 | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| November 5, 2009 | K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| July 15, 2009 | K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | DWA | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| July 2, 2009 | K091007 | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| December 17, 2008 | K082344 | STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) | DWF | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| July 30, 2008 | K080832 | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| July 6, 2007 | K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM | DTQ | Substantially Equivalent | Sorin Group Deutschland GmbH | accessdata.fda.gov |
| September 23, 2002 | K020571 | STOCKERT CENTRIFUGAL PUMP CONSOLE | DTQ | Substantially Equivalent | Stockert Instrumente GmbH | accessdata.fda.gov |
| February 5, 2002 | K011838 | CENTRIFUGAL PUMP | DWA | Substantially Equivalent | Stockert Instrumente GmbH | accessdata.fda.gov |
| December 20, 1999 | K992635 | INTERFACE MODULE IDDD | KRI | Substantially Equivalent | Stoeckert Instrumente | accessdata.fda.gov |
| January 19, 1996 | K950990 | STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE | DTQ | Substantially Equivalent | Stoeckert Instrumente | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 18, 2024 | 95665 | Class II | Ongoing | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI rese | accessdata.fda.gov |
| August 3, 2023 | 92882 | Class II | Ongoing | 3T Heater Cooler System, REF: 16-02-85 | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. | accessdata.fda.gov |
| December 17, 2021 | 89312 | Class III | Terminated | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device. | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. | accessdata.fda.gov |
| August 26, 2019 | 85505 | Class II | Terminated | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue i | accessdata.fda.gov |
| October 30, 2017 | 78594 | Class II | Terminated | 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. | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system. | accessdata.fda.gov |
| December 4, 2013 | 67199 | Class II | Terminated | 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. | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. | accessdata.fda.gov |
| September 24, 2013 | 66464 | Class II | Terminated | 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. | Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. | accessdata.fda.gov |
| February 23, 2012 | 61375 | Not yet classified | Terminated | 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. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. | accessdata.fda.gov |
Compare with other makers
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Console, Heart-Lung Machine, Cardiopulmonary Bypass
- All makers of Controller, Temperature, Cardiopulmonary Bypass
- All makers of Detector, Bubble, Cardiopulmonary Bypass
- All makers of Display, Cathode-Ray Tube, Medical
- All makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Updated November 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.