DWB · Class II · 21 CFR 870.4370

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

Leading manufacturers include Shiley, Inc..

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 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

About Product Code DWB - Regulatory Context