510(k) K150709

ProTrack RF Anchor Wire by Baylis Medical Company, Inc. — Product Code DXF

K150709 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "ProTrack RF Anchor Wire". The FDA issued a decision of Substantially Equivalent on June 17, 2015. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.