510(k) K093232

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER by Great Batch Medical — Product Code DYB

K093232 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on March 15, 2010. 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.