Extravascular Support For An Arteriovenous Fistula For Vascular Access
The Extravascular Support for an Arteriovenous Fistula for Vascular Access is a permanently implanted device placed surgically outside and/or around an artery and/or vein to provide external structural support to surgically created arteriovenous fistulas used for hemodialysis vascular access, promoting fistula maturation and longevity. Classified as FDA Class 2 under regulation 870.4600, it requires 510(k) clearance in the Cardiovascular specialty and is flagged as an implant due to its permanent surgical placement. It is not life-sustaining.
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Basic Information
- Product Code
- QVQ
- Device Class
- FDA class 2
- Regulation Number
- 870.4600
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.