LivaNova Deutschland GmbH

FDA Device Registration & Listing · MUNCHEN Bavaria, DE · Registration 9611109

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611109
FEI Number
3002808267
Entity Name
LivaNova Deutschland GmbH
City/State/Country
MUNCHEN Bavaria, DE
Establishment Address
LINDBERGH STRASSE 25, MUNCHEN Bavaria 80939, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LivaNova Deutschland GmbH (Owner Number: 8010598)
Owner / Operator Contact Address
Lindberghstrasse 25, Munich, DE-BY 80939, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080832
PMA Number
N/A

All Registered Proprietary Names

Heater-Cooler System 3T Essenz HLM XVAC Stockert Centrifugal Pump Console Sorin Centrifugal Pump 5 (CP5) ESSENZ Patient Monitor Stöckert Air Purge Control (APC) System B-Capta S3 Roller Pump and Console Sorin C5 System with EVO and Mast Pumps Stöckert Gas Blenders (2L, 5L, and 10L) Essenz ILBM XTRA Autotransfusion System Sorin C5 System Stockert S5 System IDDD S3/SC Sorin CONNECT: Data Management System 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 Stockert S5 System Stockert Centrifugal Pump (SCP) Stöckert Data Management System Sorin DataPad II Sorin B-Care5 for the Stockert S5 Stöckert EVO Sorin CONNECT Sorin B-Care5 STOCKERT HEATER COOLER SYSTEM 3T Stöckert S5 System Gas Blender

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2025-11-21
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2023-03-13
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2013-01-10
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2007-12-05
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2011-11-08
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2022-02-16
KRL Detector, Bubble, Cardiopulmonary Bypass Cardiovascular Class 2 870.4205 2011-01-25
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2021-04-14
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2007-12-05
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2011-01-25
DTX Gas Control Unit, Cardiopulmonary Bypass Cardiovascular Class 2 870.4300 2010-12-30
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2023-08-30
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2023-08-30
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2014-06-11
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2010-01-20
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2021-04-14
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2007-12-05
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2007-12-05
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2013-07-26
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2007-12-05
DWA Control, Pump Speed, Cardiopulmonary Bypass Cardiovascular Class 2 870.4380 2007-12-05
NSX N/A N/A Class N/A N/A 2010-11-02
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2009-11-10
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2009-05-04
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2017-06-13
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2011-01-25
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2020-10-29
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2008-10-16

Official Correspondent

Julie Leslie

US Agent Details

Jennifer Houck Email: Jennifer.Houck@livanova.com Phone: (717) 3838558

Related Public Records

Same Entity

LivaNova Deutschland GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K001520 Alpha Omega, Inc. ALPHA OMEGA DUAL COOLER-HEATER 2000-11-22
K881350 Stryker Corp. CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM 1988-09-30
K180534 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue GuardianSoftware 2018-07-16
K161767 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue GuardianSoftware 2017-01-27
K212208 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue GuardianSoftware (Rev. E.0X) 2021-09-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Z-0036-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Z-0038-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Z-0024-2011 Terumo Cardiovascular Systems Corporation 2
Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611109. Last updated year: 2026. Please use registration number 9611109 when referencing this establishment in official correspondence.
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