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U.S. Department of Health and Human Services

Product Classification
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Device extravascular support for an arteriovenous fistula for vascular access
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.
Physical State implant composed of stable materials (non-resorbable)
Technical Method An external vascular implant placed surgically.
Target Area various vascular beds where arteriovenous fistula are created
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQVQ
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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