510(k) K823007

OPTICATH HEPARIN COATED, FLOW-DIRECT by Oximetrix, Inc. — Product Code DYG

K823007 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "OPTICATH HEPARIN COATED, FLOW-DIRECT". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Oximetrix, Inc. has at least 10 other 510(k) clearances on record.