Device |
aspiration thrombectomy catheter |
Regulation Description |
Embolectomy catheter. |
Definition |
To remove thrombus from the peripheral and/or coronary vasculature through aspiration. |
Physical State |
Peripheral and/or coronary catheter |
Technical Method |
removed thrombus from the vasculature |
Target Area |
Peripheral and/or coronary vasculature |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QEZ |
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? |
Yes
|
Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile. |
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |