510(k) K940804

SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION by Peripheral Systems Group — Product Code ITX

K940804 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Peripheral Systems Group has at least 10 other 510(k) clearances on record.