510(k) K081341

REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) by Thomas Medical Products, Inc. — Product Code DYB

K081341 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)". The FDA issued a decision of Substantially Equivalent on May 14, 2008. 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.