510(k) K903442

ARIES TAPERSEAL(TM) SHEATH by Aries Medical, Inc. — Product Code DYB

K903442 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "ARIES TAPERSEAL(TM) SHEATH". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.