510(k) K990705

MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET by Medamicus, Inc. — Product Code DYB

K990705 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET". The FDA issued a decision of Substantially Equivalent on June 28, 1999. 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.