Device |
catheters, transluminal coronary angioplasty, percutaneous |
Regulation Description |
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. |
Definition |
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | LOX |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
510(k)
|
Regulation Number |
870.5100
|
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
|
Recognized Consensus Standard
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |