ClearanceBrief
Panels › Cardiovascular › Product code DWB · Class 2

Pump, Blood, Cardiopulmonary Bypass, Roller Type

Regulation 870.4370

0510(k)s in 12 months (21 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in DWB

Decided510(k)Device and applicantCode
Nov 17, 2016K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusio
Terumo Cardiovascular Systems Corporation
DWB
Sep 27, 2013K131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
Terumo Cardiovascular Systems Corporation
DWB
Dec 19, 2011K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
Terumo Cardiovascular Systems Corp.
DWB
Apr 27, 1998K973237CSS-CARDIOPLEGIA SAFETY SYSTEM
Medtronic Bio-Medicus, Inc.
DWB
Feb 27, 1998K972321S3 MAST PUMP
Stoeckert Instrumente
DWB
Sep 10, 1997K971520S3 CYCLIC RPM CONTROL
Stoeckert Instrumente
DWB
Jul 14, 1997K960974COBE CENTURY PERFUSION PUMP
Cobe Cardiovascular, Inc.
DWB
Apr 19, 1996K953904SARNS 9000 UNIVERSAL ROLLER PUMP
3M Health Care, Ltd.
DWB
Apr 19, 1996K953901SARNS 800 ROLLER PUMP
3M Health Care, Sarns
DWB
Feb 21, 1996K955038STOCKERT S3 DOUBLE HEAD PUMP MODULE
Stoeckert Instrumente
DWB
Apr 12, 1989K890904MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
Shiley, Inc.
DWB
Sep 28, 1988K881780VASCUCARE ANGIOPUMP
Vascucare, Inc.
DWB
Jan 12, 1988K874771ANGIOMED INTRODUCING SETS
Angiomed U.S., Inc.
DWB
Jul 16, 1986K862116STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
Shiley, Inc.
DWB
Jul 16, 1986K861714STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
Shiley, Inc.
DWB
Oct 20, 1983K831458CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
Electromedics, Inc.
DWB
Nov 1, 1982K820729SARNS PULSATILE PUMP
3M Health Care, Sarns
DWB
Aug 24, 1982K822071PUMP MODULES PMO LO-110-PMD 10-210
Gambro, Inc.
DWB
Nov 27, 1981K813035POLYSTAN VERTICLUDE BLOOD PUMP
Advocacy International, Ltd.
DWB
Nov 26, 1980K802714COBE/STOCKERT BATTERY MODULE
Cobe Laboratories, Inc.
DWB
Jun 19, 1978K780942BLOOD PUMP MODEL 7000
3M Health Care, Sarns
DWB

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