510(k) K110891

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

K110891 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER". The FDA issued a decision of Substantially Equivalent on September 13, 2011. 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.