510(k) K890277

HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT by Oscor Medical Corp. — Product Code DYB

K890277 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT". The FDA issued a decision of Substantially Equivalent on March 10, 1989. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.