510(k) K992056

ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 by Sulzer Carbomedics, Inc. — Product Code KRH

K992056 is an FDA 510(k) premarket notification submitted by Sulzer Carbomedics, Inc. for the device "ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800". The FDA issued a decision of Substantially Equivalent on October 12, 1999. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Sulzer Carbomedics, Inc. has at least 7 other 510(k) clearances on record.