510(k) K051248

VYGON MICRO-ACCESS SAFETY INTRODUCER KIT by Vygon Corp. — Product Code DYB

K051248 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "VYGON MICRO-ACCESS SAFETY INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on October 27, 2005. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Vygon Corp. has at least 10 other 510(k) clearances on record.