510(k) K004026

BRAIDED GUIDING INTRODUCER by Thomas Medical Products, Inc. — Product Code DYB

K004026 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "BRAIDED GUIDING INTRODUCER". The FDA issued a decision of Substantially Equivalent on July 9, 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.