510(k) K040150

MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER by Medamicus, Inc. — Product Code DYB

K040150 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on February 18, 2004. 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.