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Extravascular Support For An Arteriovenous Fistula For Vascular Access

FDA product code QVQ · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4600
Review panel
CV
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-02-16 – 2024-02-16

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.

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