Device |
endovascular suturing system |
Regulation Description |
Endovascular Suturing System. |
Definition |
Provides fixation and sealing between and endovascular graft and the native artery. |
Physical State |
The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture. |
Technical Method |
Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel |
Target Area |
The implant is to be placed at the proximal end of an aortic aneurysm. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | OTD |
Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.3460
|
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 |