510(k) K960310

EPIC INTRODUCER SHEATH by North American Instrument Corp. — Product Code DYB

K960310 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "EPIC INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on February 7, 1996. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. North American Instrument Corp. has at least 10 other 510(k) clearances on record.