510(k) K843719

SINGLE WALL INTRODUCER NEEDLE by Ocean Medical Products, Ltd. — Product Code DYB

K843719 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "SINGLE WALL INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on October 18, 1984. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.