510(k) K120158

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS by Thomas Medical Products, Inc. — Product Code DYB

K120158 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS". The FDA issued a decision of Substantially Equivalent on August 14, 2012. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Thomas Medical Products, Inc. has at least 10 other 510(k) clearances on record.