510(k) K052601 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
STOCKERT HEATER-COOLER SYSTEM 3T
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jun 6, 2006 |
| Received | Sep 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2020 | LivaNova USA Inc. LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures last Terminated |
DWC | None listed |
| Nov 1, 2018 | LivaNova USA Inc. SORIN Heater-Cooler System 3T 120V~/60Hz
REF 16-02-85
Description of product:
The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling syste Terminated |
DWC | None listed |
| Sep 14, 2018 | LivaNova USA Inc. SORIN Heater-Cooler System 3T, REF 16-02-85
Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extraco Terminated |
DWC | None listed |
| May 18, 2018 | LivaNova USA Sorin Stockert Heater-Cooler System 3T,
a) Item #: 16-02-81, 240 v/60 Hz;
b) Item #: 16-02-82, 208 v/60 Hz;
c) Item #: 16-02-85, 120 v/60 Hz Terminated |
DWC | None listed |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 230 V Terminated |
DWC | None listed |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 240V/60 Hz Terminated |
DWC | None listed |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 208V/60 Hz Terminated |
DWC | None listed |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 127V/60 Hz Terminated |
DWC | None listed |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 120V/60 Hz Terminated |
DWC | None listed |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz Terminated |
DWC | None listed |
| Dec 1, 2016 | Sorin Group USA, Inc. STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz
The Heater Cooler 3T is Terminated |
DWC | None listed |
| Mar 17, 2016 | Sorin Group USA, Inc. Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259 Terminated |
DWC | None listed |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 230 V
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | None listed |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | None listed |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | None listed |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | None listed |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | None listed |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.