Cleared Traditional

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

K161815 · Genesee Biomedical, Inc. · Cardiovascular
Oct 2016
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K161815 is an FDA 510(k) clearance for the FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band, a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Genesee Biomedical, Inc. (Denver, US). The FDA issued a Cleared decision on October 12, 2016, 103 days after receiving the submission on July 1, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K161815 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2016
Decision Date October 12, 2016
Days to Decision 103 days
Submission Type Traditional
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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