510(k) K112407

SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS by Smiths Medical MD, Inc. — Product Code DYB

K112407 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS". The FDA issued a decision of Substantially Equivalent on February 9, 2012. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.