510(k) K912554

ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI by Baxter Healthcare Corp — Product Code KRH

K912554 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI". The FDA issued a decision of Substantially Equivalent on Sep 9, 1991. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Baxter Healthcare Corp has 507 other 510(k) clearances on record.