510(k) K832957

FLOW-DIRECTED HEPARIN COATED THERMODIL by Sorensen Research — Product Code DYG

K832957 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "FLOW-DIRECTED HEPARIN COATED THERMODIL". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Sorensen Research has at least 10 other 510(k) clearances on record.