510(k) K070705

MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 by Vygon Corp. — Product Code FOZ

K070705 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039". The FDA issued a decision of Substantially Equivalent on November 30, 2007. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Vygon Corp. has at least 10 other 510(k) clearances on record.