Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4370](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4370) → DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type # DWB · Pump, Blood, Cardiopulmonary Bypass, Roller Type _Cardiovascular · 21 CFR 870.4370 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB ## Overview - **Product Code:** DWB - **Device Name:** Pump, Blood, Cardiopulmonary Bypass, Roller Type - **Regulation:** [21 CFR 870.4370](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4370) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K162843.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K131618.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K112587.md) | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | Terumo Cardiovascular Systems Corp. | Dec 19, 2011 | SESE | | [K973237](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K973237.md) | CSS-CARDIOPLEGIA SAFETY SYSTEM | Medtronic Bio-Medicus, Inc. | Apr 27, 1998 | SESE | | [K972321](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K972321.md) | S3 MAST PUMP | Stoeckert Instrumente | Feb 27, 1998 | SESE | | [K971520](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K971520.md) | S3 CYCLIC RPM CONTROL | Stoeckert Instrumente | Sep 10, 1997 | SESE | | [K960974](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K960974.md) | COBE CENTURY PERFUSION PUMP | Cobe Cardiovascular, Inc. | Jul 14, 1997 | SESE | | [K953904](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K953904.md) | SARNS 9000 UNIVERSAL ROLLER PUMP | 3M Health Care, Ltd. | Apr 19, 1996 | SESE | | [K953901](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K953901.md) | SARNS 800 ROLLER PUMP | 3M Health Care, Sarns | Apr 19, 1996 | SESE | | [K955038](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K955038.md) | STOCKERT S3 DOUBLE HEAD PUMP MODULE | Stoeckert Instrumente | Feb 21, 1996 | SESE | | [K890904](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K890904.md) | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP | Shiley, Inc. | Apr 12, 1989 | SESE | | [K881780](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K881780.md) | VASCUCARE ANGIOPUMP | Vascucare, Inc. | Sep 28, 1988 | SESE | | [K874771](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K874771.md) | ANGIOMED INTRODUCING SETS | Angiomed U.S., Inc. | Jan 12, 1988 | SESE | | [K862116](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K862116.md) | STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE | Shiley, Inc. | Jul 16, 1986 | SESE | | [K861714](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K861714.md) | STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE | Shiley, Inc. | Jul 16, 1986 | SESE | | [K831458](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K831458.md) | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A | Electromedics, Inc. | Oct 20, 1983 | SESE | | [K820729](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K820729.md) | SARNS PULSATILE PUMP | 3M Health Care, Sarns | Nov 1, 1982 | SESE | | [K822071](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K822071.md) | PUMP MODULES PMO LO-110-PMD 10-210 | Gambro, Inc. | Aug 24, 1982 | SESE | | [K813035](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K813035.md) | POLYSTAN VERTICLUDE BLOOD PUMP | Advocacy International, Ltd. | Nov 27, 1981 | SESE | | [K802714](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K802714.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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