510(k) K812324

FLOW-DIRECTED THERMODILUTION CATHETER by Sorensen Research — Product Code DYG

K812324 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "FLOW-DIRECTED THERMODILUTION CATHETER". The FDA issued a decision of Substantially Equivalent on September 25, 1981. 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.