510(k) K110626

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM by Pathway Medical Technologies, Inc. — Product Code MCW

K110626 is an FDA 510(k) premarket notification submitted by Pathway Medical Technologies, Inc. for the device "JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 20, 2011. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Pathway Medical Technologies, Inc. has 15 other 510(k) clearances on record.