510(k) K132022

LEMAITRE 8F OCCLUSION CATHETER by LeMaitre Vascular, Inc. — Product Code MJN

K132022 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "LEMAITRE 8F OCCLUSION CATHETER". The FDA issued a decision of Substantially Equivalent on November 6, 2013. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.