510(k) K915078

MORSE HEMOSTATIC CATHETER INTRODUCER SET by North American Instrument Corp. — Product Code DYB

K915078 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "MORSE HEMOSTATIC CATHETER INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on June 10, 1992. 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.