Device |
temporary catheter, embolic protection, transcatheter intracardiac procedures |
Regulation Description |
Temporary catheter for embolic protection during transcatheter intracardiac procedures. |
Definition |
Embolic protection for transcatheter intracardiac procedures |
Physical State |
This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end and is introduced into an artery through the skin using a guidewire. |
Technical Method |
This device is a single use percutaneous catheter system that is introduced into an artery. |
Target Area |
Aortic arch or aortic arch branch vessels. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PUM |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.1251
|
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 |