Cleared Traditional

TruForm Sievers Annuloplasty Ring

K202253 · Genesee Biomedical, Inc. · Cardiovascular
Oct 2020
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K202253 is an FDA 510(k) clearance for the TruForm Sievers Annuloplasty Ring, 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 6, 2020, 57 days after receiving the submission on August 10, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K202253 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2020
Decision Date October 06, 2020
Days to Decision 57 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

Similar Devices — KRH Ring, Annuloplasty

All 72
Seguin Annuloplasty Ring
K253232 · Abbott Medical · Oct 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
K251982 · Edwards Lifesciences, LLC · Sep 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
K251688 · Edwards Lifesciences, LLC · Sep 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · Genesee Biomedical, Inc. · Jul 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · Genesee Biomedical, Inc. · Apr 2024
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · Genesee Biomedical, Inc. · May 2023