IN-DATE
9600IS21: Edwards Certitude Introducer Sheath Set for Sapien 3: 21F x 21cm, 33mm
Photos are for illustration purposes only and may not depict the exact item.
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| Price: | $249.00 per box of 1 |
|---|---|
| Quantity: | |
| In Stock: | 23 box of 1 |
| Status: | expired |
The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in date item only.
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AccessGUDID Info
- FDA Product Code: NPU
- FDA Product Code Name: Prosthesis, Mitral Valve, Percutaneously Delivered
- FDA Product Code: NPT
- FDA Product Code Name: Aortic valve, prosthesis, percutaneously delivered
- GMDN Term Code: 58865
- GMDN Term Name: Vascular catheter introduction set, nonimplantable
- GMDN Term Description: A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
- GMDN Term Code: 60246
- GMDN Term Name: Mitral transcatheter heart valve bioprosthesis
- GMDN Term Description: 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., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included.
- GMDN Term Code: 60245
- GMDN Term Name: Aortic transcatheter heart valve bioprosthesis, stent-like framework
- GMDN Term Description: 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 transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.
Manufacturer
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Shop Clot Management, Pressure Monitoring, TD Catheters and more from Synergy Surgical's collection of Edwards products.
