DWB · Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cardiovascular · 21 CFR 870.4370 · Class 2
Overview
| Product Code | DWB |
|---|---|
| Device Name | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Regulation | 21 CFR 870.4370 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Nov 17, 2016 | SESE |
| K131618 | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST | Terumo Cardiovascular Systems Corporation | Sep 27, 2013 | SESE |
| K112587 | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | Terumo Cardiovascular Systems Corp. | Dec 19, 2011 | SESE |
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | Medtronic Bio-Medicus, Inc. | Apr 27, 1998 | SESE |
| K972321 | S3 MAST PUMP | Stoeckert Instrumente | Feb 27, 1998 | SESE |
| K971520 | S3 CYCLIC RPM CONTROL | Stoeckert Instrumente | Sep 10, 1997 | SESE |
| K960974 | COBE CENTURY PERFUSION PUMP | Cobe Cardiovascular, Inc. | Jul 14, 1997 | SESE |
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | 3M Health Care, Ltd. | Apr 19, 1996 | SESE |
| K953901 | SARNS 800 ROLLER PUMP | 3M Health Care, Sarns | Apr 19, 1996 | SESE |
| K955038 | STOCKERT S3 DOUBLE HEAD PUMP MODULE | Stoeckert Instrumente | Feb 21, 1996 | SESE |
| K890904 | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP | Shiley, Inc. | Apr 12, 1989 | SESE |
| K881780 | VASCUCARE ANGIOPUMP | Vascucare, Inc. | Sep 28, 1988 | SESE |
| K874771 | ANGIOMED INTRODUCING SETS | Angiomed U.S., Inc. | Jan 12, 1988 | SESE |
| K862116 | STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE | Shiley, Inc. | Jul 16, 1986 | SESE |
| K861714 | STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE | Shiley, Inc. | Jul 16, 1986 | SESE |
| K831458 | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A | Electromedics, Inc. | Oct 20, 1983 | SESE |
| K820729 | SARNS PULSATILE PUMP | 3M Health Care, Sarns | Nov 1, 1982 | SESE |
| K822071 | PUMP MODULES PMO LO-110-PMD 10-210 | Gambro, Inc. | Aug 24, 1982 | SESE |
| K813035 | POLYSTAN VERTICLUDE BLOOD PUMP | Advocacy International, Ltd. | Nov 27, 1981 | SESE |
| K802714 | COBE/STOCKERT BATTERY MODULE | Cobe Laboratories, Inc. | Nov 26, 1980 | SESE |
Top Applicants
- Stoeckert Instrumente — 3 clearances
- Shiley, Inc. — 3 clearances
- 3M Health Care, Sarns — 3 clearances
- Terumo Cardiovascular Systems Corporation — 2 clearances
- Vascucare, Inc. — 1 clearance
