Device |
reprocessed atherectomy catheter |
Regulation Description |
Intraluminal artery stripper. |
Definition |
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission |
Physical State |
Reprocessed Single Use Catheter with laser or mechanical cutting/shaving mechanism |
Technical Method |
Use of mechanical or laser energy to remove plaque in a lesion of the vessel |
Target Area |
Peripheral arteries |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QTF |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
510(k)
|
Regulation Number |
870.4875
|
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 |