Search Results
Found 3 results
510(k) Data Aggregation
K Number
K250859Device Name
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Manufacturer
Genesee Biomedical Inc
Date Cleared
2025-07-25
(126 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee Biomedical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K232599Device Name
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Manufacturer
Genesee Biomedical Inc
Date Cleared
2024-04-09
(225 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee Biomedical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.
Device Description
The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm Annuloplasty Ring has four green radial markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silcone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular qeometry aqainst physical expansion. The size range of TransForm is from 24mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.
Ask a Question
K Number
K230679Device Name
WellsForm Tricuspid Annuloplasty Band (WF)
Manufacturer
Genesee Biomedical Inc
Date Cleared
2023-05-26
(74 days)
Product Code
KRH, DTI
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
Genesee Biomedical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.
Device Description
The WellsForm™ Tricuspid Annuloplasty Band is an implantable ring intended for surgical repair of the tricuspid heart valve. WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.
The WellsForm™ Tricuspid Annuloplasty Band consists of a braided textile polyester body with a semi-rigid (stiflened) portion at the septal and aortic segments. The flexible section runs from the aortic segment, about half of the posteroseptal commissure to help remodel and stabilize the enlarged portion of the tricuspid annulus found in patients with functional tricuspid requrgitation.
The size range of the WellsForm Tricuspid Annuloplasty Band is from 26mm in 2mm increments (sizes: 26, 28, 30, 34, and 36).
Ask a Question
Page 1 of 1