Definition: Catheter Is Used For Percutaneous Transluminal Or Balloon Valvuloplasty (PTV) Of The Pulmonary (pulmonic) Valve. Used On Patients With Isolated Pulmonary Stenosis And Also On Patients With Valvular Pulmonary Stenosis With Other Minor Congenital Heart
| Device Type ID | 953 |
| Device Name | Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter |
| Physical State | The Device Is A Catheter With A Balloon Tip. |
| Technical Method | Catheter Contains A Ballon At The Distal End Of The Shaft. The Catheter Is Inserted Into The Body And Directed Towards The Pulmonary Valve. Once The Catheter Is Placed In The Valve, The Balloon Is Expanded Which Compresses And/or Breaks The Material |
| Target Area | The Target Area Is The Pulmonary Valve Of The Heart. |
| Regulation Description | Percutaneous Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 953 |
| Device | Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter |
| Product Code | OMZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Balloon | 2 |
Unraveled Material | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Retraction Problem | 1 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Peeled / Delaminated | 1 |
Material Rupture | 1 |
Break | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 11 |