Device |
short-term intravascular filter catheter |
Regulation Description |
Cardiovascular intravascular filter. |
Definition |
For short-term prevention of pulmonary embolism (PE) |
Physical State |
Filter attached to a catheter |
Technical Method |
Mechanically filters the bloodstream to capture blood clots |
Target Area |
Peripheral vasculature (vein), inferior vena cava (IVC) |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PNS |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
510(k)
|
Regulation Number |
870.3375
|
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 |