510(k) K983602

CV PERI-GUARD AND VASCU-GUARD by Bio-Vascular, Inc. — Product Code DXZ

K983602 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "CV PERI-GUARD AND VASCU-GUARD". The FDA issued a decision of Substantially Equivalent on November 12, 1998. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.