510(k) K911710

HEPARIN COATED THERMODILUTION CATH & ACCESSORIES by Sunscope Intl., Inc. — Product Code DQO

K911710 is an FDA 510(k) premarket notification submitted by Sunscope Intl., Inc. for the device "HEPARIN COATED THERMODILUTION CATH & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Sunscope Intl., Inc. has at least 6 other 510(k) clearances on record.