510(k) K122916

JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM by Medrad, Inc. — Product Code MCW

K122916 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2012. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Medrad, Inc. has at least 10 other 510(k) clearances on record.