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
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
Terumo Cardiovascular Systems Corporation
Cardiovascular
37d
Cleared
Sep 27, 2013
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
Terumo Cardiovascular Systems Corporation
Cardiovascular
116d
Cleared
Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
Terumo Cardiovascular Systems Corp.
Cardiovascular
104d
Cleared
Jul 14, 1997
COBE CENTURY PERFUSION PUMP
Cobe Cardiovascular, Inc.
Cardiovascular
490d
Cleared
Apr 19, 1996
SARNS 800 ROLLER PUMP
3M Health Care, Sarns
Cardiovascular
245d
Cleared
Apr 19, 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
3M Health Care, Ltd.
Cardiovascular
245d
Cleared
Apr 12, 1989
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
Shiley, Inc.
Cardiovascular
61d
Cleared
Jul 16, 1986
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
Shiley, Inc.
Cardiovascular
72d
Cleared
Jul 16, 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
Shiley, Inc.
Cardiovascular
43d
Cleared
Oct 20, 1983
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
Electromedics, Inc.
Cardiovascular
167d
Cleared
Nov 01, 1982
SARNS PULSATILE PUMP
3M Health Care, Sarns
Cardiovascular
229d
Cleared
Aug 24, 1982
PUMP MODULES PMO LO-110-PMD 10-210
Gambro, Inc.
Cardiovascular
41d
Cleared
Nov 26, 1980
COBE/STOCKERT BATTERY MODULE
Cobe Laboratories, Inc.
Cardiovascular
26d
Cleared
Jun 19, 1978
BLOOD PUMP MODEL 7000
3M Health Care, Sarns
Cardiovascular
12d