DXS · Class II · 21 CFR 870.4310

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

Leading manufacturers include Delta Medical Industries, Shiley, Inc. and 3M Health Care, Sarns.

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 Oct 31, 1991
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
K912045
Lifestream Int'L, Inc.
Cardiovascular · 176d
Cleared May 10, 1990
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797
Shiley, Inc.
Cardiovascular · 79d
Cleared Nov 06, 1987
PRESSURE BARRIER KIT CAT. NO. PBK-3
K873802
American Omni Medical, Inc.
Cardiovascular · 49d
Cleared Sep 12, 1986
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836
Shiley, Inc.
Cardiovascular · 49d
Cleared Aug 09, 1985
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232
Dlp, Inc.
Cardiovascular · 79d
Cleared Jul 26, 1983
PM-3
K831750
Delta Medical Industries
Cardiovascular · 55d
Cleared Oct 18, 1982
GAMBRO PRESSURE MONITOR PRM 10
K822822
Gambro, Inc.
Cardiovascular · 28d
Cleared May 18, 1982
PMS-2 PRESSURE MONITOR SEPARATOR
K820912
Delta Medical Industries
Cardiovascular · 47d
Cleared Dec 04, 1978
CHAMBER, MC-1 DISPOSABLE PRESSURE
K781890
Delta Medical Industries
Cardiovascular · 28d
Cleared Sep 30, 1977
CORONARY PRESSURE PERFUSION PUMP
K771764
3M Health Care, Sarns
Cardiovascular · 11d

About Product Code DXS - Regulatory Context