510(k) K101221

JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 by Pathway Medical Technologies, Inc. — Product Code MCW

K101221 is an FDA 510(k) premarket notification submitted by Pathway Medical Technologies, Inc. for the device "JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100". The FDA issued a decision of Substantially Equivalent on Jun 2, 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.