Product Code: DWB FDA class 2 21 CFR 870.4370

Pump, Blood, Cardiopulmonary Bypass, Roller Type

Cardiovascular

The Roller-Type Blood Pump for Cardiopulmonary Bypass is a life-sustaining cardiovascular device that propels blood through the extracorporeal circuit during open-heart surgery by compressing flexible tubing with rotating rollers, maintaining systemic circulation while the heart is stopped. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWB and it is regulated under 21 CFR 870.4370 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DWB
Device Class: FDA class 2
Regulation Number: 870.4370
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162843	Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1	Nov 17, 2016	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K131618	LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST	Sep 27, 2013	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K112587	ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,	Dec 19, 2011	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K973237	CSS-CARDIOPLEGIA SAFETY SYSTEM	Apr 27, 1998	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K972321	S3 MAST PUMP	Feb 27, 1998	Substantially Equivalent	Stoeckert Instrumente
K971520	S3 CYCLIC RPM CONTROL	Sep 10, 1997	Substantially Equivalent	Stoeckert Instrumente
K960974	COBE CENTURY PERFUSION PUMP	Jul 14, 1997	Substantially Equivalent	Cobe Cardiovascular, Inc.
K953904	SARNS 9000 UNIVERSAL ROLLER PUMP	Apr 19, 1996	Substantially Equivalent	3M Health Care, Ltd.
K953901	SARNS 800 ROLLER PUMP	Apr 19, 1996	Substantially Equivalent	3M Health Care, Sarns
K955038	STOCKERT S3 DOUBLE HEAD PUMP MODULE	Feb 21, 1996	Substantially Equivalent	Stoeckert Instrumente
K890904	MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP	Apr 12, 1989	Substantially Equivalent	Shiley, Inc.
K881780	VASCUCARE ANGIOPUMP	Sep 28, 1988	Substantially Equivalent	Vascucare, Inc.
K874771	ANGIOMED INTRODUCING SETS	Jan 12, 1988	Substantially Equivalent	Angiomed U.S., Inc.
K862116	STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE	Jul 16, 1986	Substantially Equivalent	Shiley, Inc.
K861714	STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE	Jul 16, 1986	Substantially Equivalent	Shiley, Inc.
K831458	CARDIOPLEGIA RECIRCULATION SYS-BL 705/A	Oct 20, 1983	Substantially Equivalent	Electromedics, Inc.
K820729	SARNS PULSATILE PUMP	Nov 01, 1982	Substantially Equivalent	3M Health Care, Sarns
K822071	PUMP MODULES PMO LO-110-PMD 10-210	Aug 24, 1982	Substantially Equivalent	Gambro, Inc.
K813035	POLYSTAN VERTICLUDE BLOOD PUMP	Nov 27, 1981	Substantially Equivalent	Advocacy International, Ltd.
K802714	COBE/STOCKERT BATTERY MODULE	Nov 26, 1980	Substantially Equivalent	Cobe Laboratories, Inc.
K780942	BLOOD PUMP MODEL 7000	Jun 19, 1978	Substantially Equivalent	3M Health Care, Sarns