510(k) K893435

SILICONE FLOW-DIRECTED THERMODILUTION CATHETER by Cathlab Corp. — Product Code DYG

K893435 is an FDA 510(k) premarket notification submitted by Cathlab Corp. for the device "SILICONE FLOW-DIRECTED THERMODILUTION CATHETER". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Cathlab Corp. has at least 7 other 510(k) clearances on record.