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FDA 510(k)

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

K-Number: K161815 · 2016-10-12

ApplicantGenesee Biomedical, Inc.
Decision Date2016-10-12
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is a medical device manufactured by Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2016-10-12 under approval number K161815. 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 FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is a medical device that received FDA 510(k) clearance on 2016-10-12. It is manufactured by Genesee Biomedical, Inc.. The 510(k) number is K161815.

When was FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band approved by the FDA?

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band received FDA 510(k) clearance on 2016-10-12, under approval number K161815.

What company makes FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is manufactured by Genesee Biomedical, Inc..

What is the FDA product code for FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

The FDA product code for FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is KRH.

Other Devices by Genesee Biomedical, Inc.

K190506NeoForm Annuloplasty Ring K202253TruForm Sievers Annuloplasty Ring K230679WellsForm Tricuspid Annuloplasty Band (WF) K232599TransForm McCarthy Mitral Annuloplasty Ring (TF) K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)

Related Devices (Code: KRH)

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. K202253TruForm Sievers 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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