510(k) K033830

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 by Opticon Medical, Inc. — Product Code EZL

K033830 is an FDA 510(k) premarket notification submitted by Opticon Medical, Inc. for the device "OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000". The FDA issued a decision of Substantially Equivalent on January 9, 2004. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Opticon Medical, Inc. has at least 7 other 510(k) clearances on record.