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FDA 510(k)

TruForm Sievers Annuloplasty Ring

K-Number: K202253 · 2020-10-06

ApplicantGenesee Biomedical, Inc.
Decision Date2020-10-06
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TruForm Sievers Annuloplasty Ring is a medical device manufactured by Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2020-10-06 under approval number K202253. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruForm Sievers Annuloplasty Ring?

TruForm Sievers Annuloplasty Ring is a medical device that received FDA 510(k) clearance on 2020-10-06. It is manufactured by Genesee Biomedical, Inc.. The 510(k) number is K202253.

When was TruForm Sievers Annuloplasty Ring approved by the FDA?

TruForm Sievers Annuloplasty Ring received FDA 510(k) clearance on 2020-10-06, under approval number K202253.

What company makes TruForm Sievers Annuloplasty Ring?

TruForm Sievers Annuloplasty Ring is manufactured by Genesee Biomedical, Inc..

What is the FDA product code for TruForm Sievers Annuloplasty Ring?

The FDA product code for TruForm Sievers Annuloplasty Ring is KRH.

Other Devices by Genesee Biomedical, Inc.

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band K190506NeoForm Annuloplasty Ring K230679WellsForm Tricuspid Annuloplasty Band (WF) K232599TransForm McCarthy Mitral Annuloplasty Ring (TF) K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)

Related Devices (Code: KRH)

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc. K181132Tri-Ad 2.0 Adams Tricuspid BandMedtronic K180411MEMO 4DSorin Group Italia S.R.L. K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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