Device typeHeart valve clip: An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.
FDA categoryTricuspid valve repair device, percutaneously delivered
Device ID05415067050847
Catalog numberTCDS0801-XT
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Depth4.0000 Millimeter
Length12.0000 Millimeter
Width22.0000 Millimeter