Device |
mechanical thrombolysis catheter |
Regulation Description |
Embolectomy catheter. |
Definition |
To mechanically disrupt thrombus and/or debris in the peripheral vasculature. |
Physical State |
Peripheral catheter |
Technical Method |
Fragments, macerates, or disrupts thrombus |
Target Area |
Peripheral vasculature |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QEY |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
510(k)
|
Regulation Number |
870.5150
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|