Device typeCardiac defect occluder: An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.
FDA categoryTranscatheter septal occluder
Device ID05415067019141
Catalog number9-ASD-006
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyMR Conditional
Outer Diameter6 Millimeter