510(k) K031949

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 by Baylis Medical Co., Inc. — Product Code DXF

K031949 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75". The FDA issued a decision of Substantially Equivalent on December 10, 2003. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.