510(k) K110051

RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT by Great Batch Medical — Product Code DYB

K110051 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on February 2, 2012. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Great Batch Medical has at least 9 other 510(k) clearances on record.