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510(k) SUMMARY FEB 1 0 2009 ACUTE CANNULA GRAFT Date prepared: 2 0th of May 2008 Revised: 10th February 2009-Page 1 of 4 Common/Usual Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing
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How to fill out vascutek cannula graft

How to fill out vascutek cannula graft:
01
Carefully clean the surgical site and ensure that it is free of any debris or contaminants.
02
Use sterile gloves to handle the vascutek cannula graft and ensure that it remains sterile throughout the procedure.
03
Fill a syringe with an appropriate sterile solution, such as heparinized saline, and attach it to the cannula graft.
04
Slowly inject the sterile solution into the graft, ensuring that it is filled completely and that there are no air bubbles.
05
Remove the syringe and securely close the opening of the cannula graft, ensuring that it is tightly sealed to prevent any leakage.
06
Double-check the graft to ensure that it is properly filled and sealed before proceeding with the surgical procedure.
Who needs vascutek cannula graft:
01
Patients who require vascular access for hemodialysis, particularly for those with end-stage renal disease.
02
Individuals undergoing cardiac surgery, such as coronary artery bypass grafting, who may require a bypass graft for improved blood flow.
03
Patients with peripheral arterial disease who require a bypass graft to restore blood flow to affected limbs.
04
Individuals with aortic aneurysms or dissections who may require grafts for repair or replacement of the diseased portion of the aorta.
05
Patients with certain congenital heart defects who require surgical interventions, such as the Fontan procedure, where cannula grafts may be used for improved venous return.
06
Individuals who require vascular access for other therapeutic procedures, such as plasmapheresis or chemotherapy infusion.
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What is vascutek cannula graft?
Vascutek cannula graft is a medical device used in cardiovascular surgery to provide access and support for cardiopulmonary bypass procedures.
Who is required to file vascutek cannula graft?
There is no specific requirement to file vascutek cannula graft. However, surgeons and hospitals using this medical device keep records of its usage for medical and regulatory purposes.
How to fill out vascutek cannula graft?
Filling out vascutek cannula graft involves documenting the surgical procedure where it is used, including patient information, details of the surgery, and relevant medical data. It is typically done by the surgical team or healthcare professionals involved.
What is the purpose of vascutek cannula graft?
The purpose of vascutek cannula graft is to provide a reliable and safe access point for initiating cardiopulmonary bypass during cardiovascular surgery. It allows for the redirection of blood flow to the heart-lung machine for oxygenation and circulation.
What information must be reported on vascutek cannula graft?
The information typically reported on vascutek cannula graft includes patient demographics, the surgical procedure performed, details of the graft used, any complications or adverse events, and the outcomes of the surgery.
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