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DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DXS
Device Class
Class II
Regulation Number
870.4310
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K113235medtronicPRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSDecember 2, 2011
K944764vascular technology incorporatedVTI DISPOSABLE PRESSURE DISPLAY SETDecember 27, 1994
K912045lifestream int'lTMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTOctober 31, 1991
K900797shileySTOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRMay 10, 1990
K873802american omni medicalPRESSURE BARRIER KIT CAT. NO. PBK-3November 6, 1987
K862836shileySTOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULESeptember 12, 1986
K852232dlpPRESSURE DISPLAY BOX #60000/TUBING SET #61000August 9, 1985
K842194norton texas medical productsPRESSURE MONITORAugust 27, 1984
K831750delta medical industriesPM-3July 26, 1983
K822822gambroGAMBRO PRESSURE MONITOR PRM 10October 18, 1982
K820912delta medical industriesPMS-2 PRESSURE MONITOR SEPARATORMay 18, 1982
K781890delta medical industriesCHAMBER, MC-1 DISPOSABLE PRESSUREDecember 4, 1978
K7717643m health care, sarnsCORONARY PRESSURE PERFUSION PUMPSeptember 30, 1977