Cleared Special

Tri-Ad 2.0 Adams Tricuspid Band

K181132 · Medtronic · Cardiovascular
May 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K181132 is an FDA 510(k) clearance for the Tri-Ad 2.0 Adams Tricuspid Band, a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Medtronic (Santa Ana, US). The FDA issued a Cleared decision on May 29, 2018, 29 days after receiving the submission on April 30, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K181132 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2018
Decision Date May 29, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRH — Ring, Annuloplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3800

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