Device |
laser-powered inferior vena cava filter retrieval catheter |
Definition |
A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters. |
Physical State |
Laser catheter |
Technical Method |
Removal of indwelling IVF filter through ablation of tissue. |
Target Area |
Inferior Vena Cava |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QRJ |
Premarket Review |
Coronary and Peripheral Interventional Devices
(DHT2C)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
510(k)
|
Regulation Number |
870.5125
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |