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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 the device name listed in this FDA 510(k) record. The listed applicant is Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2016-10-12 under 510(k) 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. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K161815.

When did FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band receive FDA 510(k) clearance?

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

Who is the listed applicant for FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

The FDA 510(k) record lists Genesee Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04761120Annuloplasty Rings and Band Post-Market Clinical Follow-Up StudyRECRUITING

Other records listing Genesee Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)K230679WellsForm Tricuspid Annuloplasty Band (WF)K202253TruForm Sievers Annuloplasty RingK190506NeoForm Annuloplasty Ring

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Related Devices (Code: KRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee 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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