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 Code | QVQ |
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 |