510(k) K900710

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER by Intec Medical, Inc. — Product Code KRB

K900710 is an FDA 510(k) premarket notification submitted by Intec Medical, Inc. for the device "INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER". The FDA issued a decision of Substantially Equivalent on October 19, 1990. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Intec Medical, Inc. has at least 10 other 510(k) clearances on record.