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FDA 510(k)

WellsForm Tricuspid Annuloplasty Band (WF)

K-Number: K230679 · 2023-05-26

ApplicantGenesee Biomedical, Inc.
Decision Date2023-05-26
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WellsForm Tricuspid Annuloplasty Band (WF) is a medical device manufactured by Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2023-05-26 under approval number K230679. 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 WellsForm Tricuspid Annuloplasty Band (WF)?

WellsForm Tricuspid Annuloplasty Band (WF) is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Genesee Biomedical, Inc.. The 510(k) number is K230679.

When was WellsForm Tricuspid Annuloplasty Band (WF) approved by the FDA?

WellsForm Tricuspid Annuloplasty Band (WF) received FDA 510(k) clearance on 2023-05-26, under approval number K230679.

What company makes WellsForm Tricuspid Annuloplasty Band (WF)?

WellsForm Tricuspid Annuloplasty Band (WF) is manufactured by Genesee Biomedical, Inc..

What is the FDA product code for WellsForm Tricuspid Annuloplasty Band (WF)?

The FDA product code for WellsForm Tricuspid Annuloplasty Band (WF) is KRH.

Related Clinical Trials

NCT04634266 TRICuspid Intervention in Heart Failure Trial ACTIVE_NOT_RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT06479824 NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study SUSPENDED

Other Devices by Genesee Biomedical, Inc.

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band K190506NeoForm Annuloplasty Ring K202253TruForm Sievers Annuloplasty Ring 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. K202253TruForm Sievers Annuloplasty RingGenesee Biomedical, 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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