510(k) K121839

UNBALLOON NON-OCCLUSIVE MODELING CATHETER by LeMaitre Vascular, Inc. — Product Code DQY

K121839 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "UNBALLOON NON-OCCLUSIVE MODELING CATHETER". The FDA issued a decision of Substantially Equivalent on August 8, 2012. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.