| Device |
vessel guard or cover |
| Regulation Description |
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
| Definition |
These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels. |
| Physical State |
a 2-dimensional material |
| Technical Method |
The material is cut to size, then laid over a blood vessel and sutured/tacked into nearby tissue to keep it from migrating |
| Target Area |
over a blood vessel, typically the aorta during anterior vertebral surgery |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OMR |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.3470
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
