510(k) K141051

VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU by Arrow International, Inc. — Product Code MSD

K141051 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. for the device "VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU". The FDA issued a decision of Substantially Equivalent on July 7, 2014. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Arrow International, Inc. has at least 10 other 510(k) clearances on record.