A flexible tube intended to be used to deploy and implant a heart valve bioprosthesis (not included) during a minimally invasive transcatheter procedure via transarterial access (e.g., femoral, subclavian, aortic) under fluoroscopic guidance. It typically c...

Cadaveric pulmonary artery bioprosthesis

355 GUDID devices

A non-sterile, implantable, heart tissue allograft obtained from a human cadaver intended to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularize...

Aortic heart valve bioprosthesis

310 GUDID devices

A sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue...

Cadaveric pulmonary artery bioprosthesis

158 GUDID devices

An implantable heart tissue allograft obtained from a human cadaver intended to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be ...

Mitral heart valve bioprosthesis

87 GUDID devices

A sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue...

Aortic transcatheter heart valve bioprosthesis, stent-like framework

85 GUDID devices

A sterile implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial...

Pulmonary heart valve bioprosthesis

69 GUDID devices

A sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (...

Aortic heart valve bioprosthesis

60 GUDID devices

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, o...

Mitral transcatheter heart valve bioprosthesis

31 GUDID devices

An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfem...

Aortic transcatheter heart valve bioprosthesis, stent-like framework

28 GUDID devices

An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transar...

Pulmonary transcatheter heart valve bioprosthesis

18 GUDID devices

A sterile implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and wh...

Aortic heart valve bioprosthesis/synthetic polymer aorta graft

14 GUDID devices

A sterile implantable xenograft (e.g., porcine or bovine heart valve) fitted with a length of synthetic polymer blood vessel (vascular graft) intended to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased asce...

Aortic transcatheter heart valve bioprosthesis, stent-like framework

12 GUDID devices

An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarteri...

Mitral heart valve bioprosthesis

10 GUDID devices

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, o...

Cardiovascular implant implantation tool base

9 GUDID devices

A plate-like device intended to function as a sturdy support (base) for the holder/implantation tool of a cardiovascular implant (e.g., biologic-polymer aorta graft, heart valve bioprosthesis). It may be made of plastic and/or metallic material and includes...

Pulmonary transcatheter heart valve bioprosthesis

9 GUDID devices

An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is ...

Pulmonary heart valve bioprosthesis

6 GUDID devices

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) pr...

Self-expandable heart valve bioprosthesis collapsing tool, single-use

6 GUDID devices

A dedicated, manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery so the collapsed valve can be mounted onto a dedicated holder or catheter to facilitat...

Mitral open-surgery heart valve bioprosthesis

5 GUDID devices

Self-expandable heart valve bioprosthesis collapsing tool, single-use

5 GUDID devices

A sterile manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery to enable the collapsed valve to be mounted onto a dedicated holder or catheter to facili...

Tricuspid open-surgery heart valve bioprosthesis

5 GUDID devices

A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional tricuspid heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only...

Tricuspid transcatheter heart valve bioprosthesis

5 GUDID devices

An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant tricuspid heart valve, or previously-implanted tricuspid heart valve prosthesis, and which is implanted using a catheter via percutaneous access (e.g., t...

Aortic heart valve bioprosthesis/synthetic polymer aorta graft

4 GUDID devices

An implantable xenograft (e.g., porcine or bovine heart valve) fitted with a length of synthetic polymer blood vessel (vascular graft) intended to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending a...

Pulmonary open-surgery heart valve bioprosthesis

4 GUDID devices

Valve-non-specific transcatheter heart valve bioprosthesis

2 GUDID devices

An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant heart valve or a previously-implanted heart valve prosthesis, via percutaneous transcatheter access, and that is not dedicated to replacement of any one ...

Heart valve prosthesis holder safety clip

1 GUDID devices

A sterile device intended to be attached to a heart valve prosthesis holder during open surgical implantation of a self-expandable heart valve bioprosthesis, to position, secure, and prevent accidental release of the heart valve prosthesis holderâ€™s holdin...