510(k) K102948

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

K102948 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 April 1, 2011. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.