510(k) K911840

INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER by Intec Medical, Inc. — Product Code DYG

K911840 is an FDA 510(k) premarket notification submitted by Intec Medical, Inc. for the device "INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER". The FDA issued a decision of Substantially Equivalent on June 3, 1991. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Intec Medical, Inc. has at least 10 other 510(k) clearances on record.