Pump, Blood, Cardiopulmonary Bypass, Roller Type
FDA product code DWB · Class II (moderate risk) · 21 CFR 870.4370 · Cardiovascular
21510(k) clearances
0PMA approvals
2recalls
Manufacturers
- 3M Health Care, Sarns 3
- Shiley, Inc. 3
- Stoeckert Instrumente 3
- Terumo Cardiovascular Systems Corporation 3
- Cobe Laboratories, Inc. 1
- Advocacy International, Ltd. 1
- Gambro, Inc. 1
- Electromedics, Inc. 1
- Angiomed U.S., Inc. 1
- Vascucare, Inc. 1
- 3M Health Care, Ltd. 1
- Cobe Cardiovascular, Inc. 1
- Medtronic Bio-Medicus, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | Terumo Cardiovascular Systems Corporation | 11/17/2016SE |
| K131618 | Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional | Terumo Cardiovascular Systems Corporation | 09/27/2013SE |
| K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional | Terumo Cardiovascular Systems Corp. | 12/19/2011SE |
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | Medtronic Bio-Medicus, Inc. | 04/27/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | Stoeckert Instrumente | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 3M Health Care, Sarns | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
| K890904 | Modified Stockert-Shiley Caps Multi. Roller PumpDWB · Traditional | Shiley, Inc. | 04/12/1989SE |
| K881780 | Vascucare AngiopumpDWB · Traditional | Vascucare, Inc. | 09/28/1988SE |
| K874771 | Angiomed Introducing SetsDWB · Traditional | Angiomed U.S., Inc. | 01/12/1988SE |
| K862116 | Stockert-Shiley Double Head Pump ModuleDWB · Traditional | Shiley, Inc. | 07/16/1986SE |
| K861714 | Stockert-Shiley Multiflow Roller Pump ModuleDWB · Traditional | Shiley, Inc. | 07/16/1986SE |
| K831458 | Cardioplegia Recirculation Sys-Bl 705/ADWB · Traditional | Electromedics, Inc. | 10/20/1983SE |
| K820729 | Sarns Pulsatile PumpDWB · Traditional | 3M Health Care, Sarns | 11/01/1982SE |
| K822071 | Pump Modules Pmo LO-110-PMD 10-210DWB · Traditional | Gambro, Inc. | 08/24/1982SE |
| K813035 | Polystan Verticlude Blood PumpDWB · Traditional | Advocacy International, Ltd. | 11/27/1981SE |
| K802714 | Cobe/Stockert Battery ModuleDWB · Traditional | Cobe Laboratories, Inc. | 11/26/1980SE |
| K780942 | Blood Pump Model 7000DWB · Traditional | 3M Health Care, Sarns | 06/19/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0303-2012 | Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular…Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board… | Terumo Cardiovascular Systems Corporation | 10/21/2011Terminated |
| Z-3214-2011 | Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO…The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery… | Terumo Cardiovascular Systems Corporation | 08/29/2011Terminated |