Cleared Traditional

WellsForm Tricuspid Annuloplasty Band (WF)

K230679 · Genesee Biomedical, Inc. · Cardiovascular
May 2023
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K230679 is an FDA 510(k) clearance for the WellsForm Tricuspid Annuloplasty Band (WF), a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Genesee Biomedical, Inc. (Denver, US). The FDA issued a Cleared decision on May 26, 2023, 74 days after receiving the submission on March 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K230679 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2023
Decision Date May 26, 2023
Days to Decision 74 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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