510(k) K022257

VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX by Vomed Volzer Medizintechnik GmbH & Co. — Product Code DRC

K022257 is an FDA 510(k) premarket notification submitted by Vomed Volzer Medizintechnik GmbH & Co. for the device "VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX". The FDA issued a decision of Substantially Equivalent on October 4, 2002. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Vomed Volzer Medizintechnik GmbH & Co. has at least 2 other 510(k) clearances on record.