DWB · Class II · 21 CFR 870.4370

FDA Product Code DWB: Pump, Blood, Cardiopulmonary Bypass, Roller Type

Leading manufacturers include 3M Health Care, Sarns, Shiley, Inc. and Terumo Cardiovascular Systems Corporation.

21
Total
21
Cleared
136d
Avg days
1978
Since

FDA 510(k) Cleared Pump, Blood, Cardiopulmonary Bypass, Roller Type Devices (Product Code DWB)

21 devices
1–21 of 21
Cleared Nov 17, 2016
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
K162843
Terumo Cardiovascular Systems Corporation
Cardiovascular · 37d
Cleared Sep 27, 2013
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
K131618
Terumo Cardiovascular Systems Corporation
Cardiovascular · 116d
Cleared Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
K112587
Terumo Cardiovascular Systems Corp.
Cardiovascular · 104d
Cleared Jul 14, 1997
COBE CENTURY PERFUSION PUMP
K960974
Cobe Cardiovascular, Inc.
Cardiovascular · 490d
Cleared Apr 19, 1996
SARNS 800 ROLLER PUMP
K953901
3M Health Care, Sarns
Cardiovascular · 245d
Cleared Apr 19, 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
K953904
3M Health Care, Ltd.
Cardiovascular · 245d
Cleared Apr 12, 1989
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904
Shiley, Inc.
Cardiovascular · 61d
Cleared Jul 16, 1986
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714
Shiley, Inc.
Cardiovascular · 72d
Cleared Jul 16, 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116
Shiley, Inc.
Cardiovascular · 43d
Cleared Oct 20, 1983
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
K831458
Electromedics, Inc.
Cardiovascular · 167d
Cleared Nov 01, 1982
SARNS PULSATILE PUMP
K820729
3M Health Care, Sarns
Cardiovascular · 229d
Cleared Aug 24, 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071
Gambro, Inc.
Cardiovascular · 41d
Cleared Nov 26, 1980
COBE/STOCKERT BATTERY MODULE
K802714
Cobe Laboratories, Inc.
Cardiovascular · 26d
Cleared Jun 19, 1978
BLOOD PUMP MODEL 7000
K780942
3M Health Care, Sarns
Cardiovascular · 12d

About Product Code DWB - Regulatory Context