510(k) K042399

MODIFICATION TO SHORT INTRODUCER SHEATH by Rex Medical, L.P. — Product Code DYB

K042399 is an FDA 510(k) premarket notification submitted by Rex Medical, L.P. for the device "MODIFICATION TO SHORT INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Rex Medical, L.P. has at least 7 other 510(k) clearances on record.