Definition: To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
| Device Type ID | 973 |
| Device Name | Catheter, Percutaneous, Cutting/scoring |
| Physical State | Cutting/scoring Catheters Are Usually Comprised Of Flexible Polymers For The Catheter Body And A Compliant Polymer For The Balloon. The Cutting/scoring Elements Are Usually Metal. |
| Technical Method | The Device Is Typically Placed Using A Guidewire And Guiding Catheter. The Active End Is Typically Expanded And The Cutting/scoring Surfaces Are Apposed To The Vessel Wall To Cause Cracking Or Breaking Of The Stenosis. |
| Target Area | Peripheral Arteries And Arteriovenous Dialysis Fistulae |
| Regulation Description | Percutaneous Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 973 |
| Device | Catheter, Percutaneous, Cutting/scoring |
| Product Code | PNO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIOSCORE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRANETICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VENTUREMED GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 27 |
Material Rupture | 17 |
Detachment Of Device Or Device Component | 13 |
Break | 5 |
Deflation Problem | 5 |
Burst Container Or Vessel | 3 |
Inflation Problem | 2 |
Failure To Advance | 2 |
Retraction Problem | 2 |
Entrapment Of Device | 2 |
Detachment Of Device Component | 2 |
Leak / Splash | 1 |
Device-Device Incompatibility | 1 |
Material Deformation | 1 |
| Total Device Problems | 83 |