System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
The Endovascular Graft for Arteriovenous (AV) Dialysis Access Circuit Stenosis Treatment is a stent graft device intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access for hemodialysis by treating stenotic lesions or thrombotic occlusions. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the high-risk nature of vascular implants used in dialysis patients. The product code is PFV, reviewed by the Cardiovascular (CV) panel, with no regulation number assigned. This device carries an implant flag given its endovascular placement.
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Basic Information
- Product Code
- PFV
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.