510(k) K961246

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M by St. Jude Medical, Inc. — Product Code KRH

K961246 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M". The FDA issued a decision of ST on February 14, 1997. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.