510(k) K014161

SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) by St. Jude Medical, Inc. — Product Code KRH

K014161 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)". The FDA issued a decision of Substantially Equivalent on January 15, 2002. 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.