510(k) K004025

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

K004025 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "SPLITTABLE SHEATH INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on July 19, 2001. 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.