DXS · Class II · 21 CFR 870.4310

FDA Product Code DXS: Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Leading manufacturers include Shiley, Inc. and Medtronic, Inc..

13
Total
13
Cleared
62d
Avg days
1977
Since

FDA 510(k) Cleared Gauge, Pressure, Coronary, Cardiopulmonary Bypass Devices (Product Code DXS)

13 devices
1–13 of 13
Cleared Dec 02, 2011
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235
Medtronic, Inc.
Cardiovascular · 30d
Cleared May 10, 1990
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797
Shiley, Inc.
Cardiovascular · 79d
Cleared Sep 12, 1986
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836
Shiley, Inc.
Cardiovascular · 49d

About Product Code DXS - Regulatory Context