DWB · Class II · 21 CFR 870.4370

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

Leading manufacturers include Shiley, Inc., Stoeckert Instrumente and 3M Health Care, Sarns.

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 Apr 27, 1998
CSS-CARDIOPLEGIA SAFETY SYSTEM
K973237
Medtronic Bio-Medicus, Inc.
Cardiovascular · 242d
Cleared Feb 27, 1998
S3 MAST PUMP
K972321
Stoeckert Instrumente
Cardiovascular · 249d
Cleared Sep 10, 1997
S3 CYCLIC RPM CONTROL
K971520
Stoeckert Instrumente
Cardiovascular · 138d
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 Feb 21, 1996
STOCKERT S3 DOUBLE HEAD PUMP MODULE
K955038
Stoeckert Instrumente
Cardiovascular · 110d
Cleared Apr 12, 1989
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904
Shiley, Inc.
Cardiovascular · 61d
Cleared Jan 12, 1988
ANGIOMED INTRODUCING SETS
K874771
Angiomed U.S., Inc.
Cardiovascular · 54d
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