510(k) K844022

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH by Electro-Catheter Corp. — Product Code DXG

K844022 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH VENTRICULAR PACING THERMAL DILUTION CATH". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.