510(k) K181132

Tri-Ad 2.0 Adams Tricuspid Band by Medtronic — Product Code KRH

K181132 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Tri-Ad 2.0 Adams Tricuspid Band". The FDA issued a decision of Substantially Equivalent on May 29, 2018. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Medtronic has at least 10 other 510(k) clearances on record.