510(k) K010253

ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 by Transonic Systems, Inc. — Product Code DYG

K010253 is an FDA 510(k) premarket notification submitted by Transonic Systems, Inc. for the device "ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101". The FDA issued a decision of Substantially Equivalent on March 19, 2002. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Transonic Systems, Inc. has at least 10 other 510(k) clearances on record.