510(k) K852612

METRONIC MODEL F7700 HEART VALVE SIZERS by Medtronic Vascular — Product Code DTI

K852612 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "METRONIC MODEL F7700 HEART VALVE SIZERS". The FDA issued a decision of Substantially Equivalent on September 23, 1985. The device falls under product code DTI (Sizer, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3945. Medtronic Vascular has at least 10 other 510(k) clearances on record.