510(k) K821235

HEPARIN COATED THERMODILUTION CATHETER by Gould, Inc. — Product Code DYG

K821235 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "HEPARIN COATED THERMODILUTION CATHETER". The FDA issued a decision of Substantially Equivalent on May 18, 1982. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Gould, Inc. has at least 10 other 510(k) clearances on record.