510(k) K013202

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

K013202 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "MODIFICATION TO BRAIDED GUIDING INTRODUCER". The FDA issued a decision of Substantially Equivalent on October 23, 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.