510(k) K093918

JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) by Pathway Medical Technologies, Inc. — Product Code MCW

K093918 is an FDA 510(k) premarket notification submitted by Pathway Medical Technologies, Inc. for the device "JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)". The FDA issued a decision of Substantially Equivalent on Jan 21, 2010. 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.