Product code DXS— Cardiovascular

FDA has cleared 13 devices under product code DXS between 1977 and 2011, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20111 clearance
• 19941 clearance
• 19911 clearance
• 19901 clearance
• 19871 clearance
• 19861 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19822 clearances
• 19781 clearance
• 19771 clearance

• Delta Medical Industries3 clearances
• Shiley, Inc.2 clearances
• Vascular Technology Incorporated1 clearance
• Norton Texas Medical Products1 clearance
• Medtronic, Inc.1 clearance
• Lifestream Int'L, Inc.1 clearance
• Gambro, Inc.1 clearance
• Dlp, Inc.1 clearance
• American Omni Medical, Inc.1 clearance
• 3M Health Care, Sarns1 clearance

• K113235 — PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.·2011-12-02
• K944764 — VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology Incorporated·1994-12-27
• K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.·1991-10-31
• K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.·1990-05-10
• K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3American Omni Medical, Inc.·1987-11-06
• K862836 — STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, Inc.·1986-09-12
• K852232 — PRESSURE DISPLAY BOX #60000/TUBING SET #61000Dlp, Inc.·1985-08-09
• K842194 — PRESSURE MONITORNorton Texas Medical Products·1984-08-27
• K831750 — PM-3Delta Medical Industries·1983-07-26
• K822822 — GAMBRO PRESSURE MONITOR PRM 10Gambro, Inc.·1982-10-18
• K820912 — PMS-2 PRESSURE MONITOR SEPARATORDelta Medical Industries·1982-05-18
• K781890 — CHAMBER, MC-1 DISPOSABLE PRESSUREDelta Medical Industries·1978-12-04
• K771764 — CORONARY PRESSURE PERFUSION PUMP3M Health Care, Sarns·1977-09-30