510(k) K893658

PERCUTANEOUS INTRODUCER by Medamicus, Inc. — Product Code DYB

K893658 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "PERCUTANEOUS INTRODUCER". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medamicus, Inc. has at least 10 other 510(k) clearances on record.