510(k) K831401

SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS by Med-West, Inc. — Product Code FIQ

K831401 is an FDA 510(k) premarket notification submitted by Med-West, Inc. for the device "SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS". The FDA issued a decision of Substantially Equivalent on June 3, 1983. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Med-West, Inc. has at least 10 other 510(k) clearances on record.