510(k) K013919

TORFLEX TRANSSEPTAL GUIDING SHEATH by Baylis Medical Co., Inc. — Product Code DBY

K013919 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "TORFLEX TRANSSEPTAL GUIDING SHEATH". The FDA issued a decision of Substantially Equivalent on February 22, 2002. The device falls under product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.