Definition: Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature.
| Device Type ID | 976 |
| Device Name | Percutaneous Catheter, Ultrasound |
| Physical State | Catheters That Deliver Electro-mechanical Energy To A Blood Vessel Via A Catheter Which Is Connected Via A Cable To A Generator. |
| Technical Method | Delivered Through The Peripheral Arterial System. Use Of Shockwave To Disrupt Plaque Or Blood Clot. |
| Target Area | Peripheral Vasculature |
| 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 | PPN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 976 |
| Device | Percutaneous Catheter, Ultrasound |
| Product Code | PPN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SHOCKWAVE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Balloon | 2 |
Material Split, Cut Or Torn | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Patient Device Interaction Problem | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Shockwave Medical, Inc. | II | Sep-25-2018 |