510(k) K022363

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

K022363 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)". The FDA issued a decision of Substantially Equivalent on September 19, 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.