| Device |
covered stent vascular connector, hemodialysis access circuit |
| Definition |
The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site. |
| Physical State |
Metal scaffold encapsulated in fabric material. |
| Technical Method |
The device is used to create a connection between an AV graft and native vessel or between two native vessels to create a hemodialysis access site. The implant is inserted into the native vessel or vascular graft, either manually or via a delivery system to create the connection. Suture attachment is not necessary to secure the device on one or both ends. |
| Target Area |
arteriovenous dialysis access circuit, upper and lower limbs |
| Review Panel |
Cardiovascular |
|---|
| Product Code | SEQ |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| 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 |
