Panels › Cardiovascular › Product code DWA · Class 2
Control, Pump Speed, Cardiopulmonary Bypass
Regulation 870.4380
0510(k)s in 12 months (37 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DWA
| Company | 510(k)s | Recalls |
|---|---|---|
| Levitronix, LLC | 6 | 0 |
| Medtronic Bio-Medicus, Inc. | 6 | 0 |
| Sorin Group Deutschland GmbH | 3 | 3 |
| Bio Medicus, Inc. | 3 | 0 |
| LivaNova Deutschland GmbH | 0 | 3 |
| Medtronic Perfusion Systems | 2 | 1 |
| Stockert Instrumente GmbH | 3 | 0 |
| Apmtd, Inc. | 2 | 0 |
| Cardiac Assist, Inc | 0 | 2 |
| Medtronic | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2023 | Cardiac Assist, Inc SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000;
SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit Terminated |
DWA | K183623 |
| Sep 23, 2022 | Cardiac Assist, Inc TANDEM LIFE LivaNova LIFESPARC Controller;
Controller and Accessories Model 5900-0000;
Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass. Terminated |
DWA | K183623 |
| 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 | K112225 |
| Mar 3, 2021 | Medtronic Perfusion Systems Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures. Open, Classified |
DWA | K131964 |
| Aug 26, 2019 | LivaNova Deutschland GmbH Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI:
04033817900986 Terminated |
DWA | K011838 |
| Aug 26, 2019 | LivaNova Deutschland GmbH Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 Terminated |
DWA | K011838 |
| 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 |
| Oct 29, 2012 | Sorin Group USA, Inc. SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954.
The SCP is a cardiopulmonary bypass speed control device indicated for use ex Terminated |
DWA | K011838 |
| Oct 29, 2012 | Sorin Group USA, Inc. SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.
The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively Terminated |
DWA | K011838 |
| 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 |
| Jun 30, 2010 | Medtronic Cardiovascular Revascularization & Surgical Therap Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed Terminated |
DWA | K051303 K941921 +1 |
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