510(k) K043438

LARGE BORE SPLITTABLE INTRODUCER KIT by Thomas Medical Products, Inc. — Product Code DYB

K043438 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "LARGE BORE SPLITTABLE INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on February 15, 2005. 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.