510(k) K020090

MODIFICATION TO TRANSSEPTAL INTRODUCER SET by Thomas Medical Products, Inc. — Product Code DYB

K020090 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "MODIFICATION TO TRANSSEPTAL INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on February 11, 2002. 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.