510(k) K092332

JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) by Pathway Medical Technologies, Inc. — Product Code MCW

K092332 is an FDA 510(k) premarket notification submitted by Pathway Medical Technologies, Inc. for the device "JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)". The FDA issued a decision of Substantially Equivalent on Sep 3, 2009. 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.