510(k) K112225 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
SORIN CENTRIFUGAL PUMP 5 (CP5)
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Sep 20, 2011 |
| Received | Aug 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2021 | LivaNova Deutschland GmbH 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. Terminated |
DWA | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.