FDA 510(k) Applications for Medical Device Product Code "DXS"
(Gauge, Pressure, Coronary, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K771764 3M HEALTH CARE, SARNS CORONARY PRESSURE PERFUSION PUMP 09/30/1977
K873802 AMERICAN OMNI MEDICAL, INC. PRESSURE BARRIER KIT CAT. NO. PBK-3 11/06/1987
K781890 DELTA MEDICAL INDUSTRIES CHAMBER, MC-1 DISPOSABLE PRESSURE 12/04/1978
K831750 DELTA MEDICAL INDUSTRIES PM-3 07/26/1983
K820912 DELTA MEDICAL INDUSTRIES PMS-2 PRESSURE MONITOR SEPARATOR 05/18/1982
K852232 DLP, INC. PRESSURE DISPLAY BOX #60000/TUBING SET #61000 08/09/1985
K822822 GAMBRO, INC. GAMBRO PRESSURE MONITOR PRM 10 10/18/1982
K912045 LIFESTREAM INT'L, INC. TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST 10/31/1991
K113235 MEDTRONIC INC. PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS 12/02/2011
K842194 NORTON TEXAS MEDICAL PRODUCTS PRESSURE MONITOR 08/27/1984
K900797 SHILEY, INC. STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR 05/10/1990
K862836 SHILEY, INC. STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE 09/12/1986
K944764 VASCULAR TECHNOLOGY INCORPORATED VTI DISPOSABLE PRESSURE DISPLAY SET 12/27/1994


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact