510(k) K932777

SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER by Peripheral Systems Group — Product Code ITX

K932777 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER". The FDA issued a decision of Substantially Equivalent on October 7, 1993. 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.