Definition: A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
| Device Type ID | 958 |
| Device Name | Balloon Aortic Valvuloplasty |
| Physical State | Generally, A Balloon Aortic Valvuloplasty Catheter Is A Coaxial Catheter Comprised Of Outer And Inner Layers. The Catheter Features A Molded Proximal End Bifurcated With Two Distinct Luminal Passages. The Inflation Lumen Terminates Into A Distally Mo |
| Technical Method | The Catheter Is Inserted Into The Body And Directed Towards The Aortic Valve. Once The Catheter Is Placed In The Valve, The Balloon Is Expanded Which Compresses And/or Breaks The Material Causing Stenosis. |
| Target Area | The Aortic Valve Of The Heart. |
| Regulation Description | Balloon Aortic Valvuloplasty Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1255 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 958 |
| Device | Balloon Aortic Valvuloplasty |
| Product Code | OZT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Balloon Aortic Valvuloplasty Catheter. |
| CFR Regulation Number | 870.1255 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INTERVALVE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Rupture | 18 |
Aspiration Issue | 16 |
Retraction Problem | 14 |
Deflation Problem | 10 |
Leak / Splash | 9 |
Detachment Of Device Or Device Component | 6 |
Peeled / Delaminated | 5 |
Break | 4 |
Difficult To Insert | 3 |
Device-Device Incompatibility | 3 |
Unintended Movement | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Inflation Problem | 2 |
Device Operates Differently Than Expected | 2 |
Hole In Material | 2 |
Crack | 2 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Device Markings / Labelling Problem | 1 |
Material Deformation | 1 |
Difficult To Remove | 1 |
Loss Of Or Failure To Bond | 1 |
Use Of Device Problem | 1 |
Suction Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Catheter | 1 |
| Total Device Problems | 112 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | InterValve Inc | II | May-15-2014 |