510(k) K112541

Z FLEX-270TM STEERABLE SHEATH by Great Batch Medical — Product Code DRA

K112541 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "Z FLEX-270TM STEERABLE SHEATH". The FDA issued a decision of Substantially Equivalent on February 7, 2012. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Great Batch Medical has at least 9 other 510(k) clearances on record.