| Device Type ID | 5605 |
| Device Name | Catheter, Balloon Type |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GBA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5605 |
| Device | Catheter, Balloon Type |
| Product Code | GBA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 86 |
Leak / Splash | 32 |
Gauges/Meters | 21 |
Incorrect Measurement | 21 |
Material Rupture | 9 |
Display Or Visual Feedback Problem | 7 |
Fluid Leak | 7 |
Break | 5 |
Air Leak | 4 |
Burst Container Or Vessel | 4 |
Hole In Material | 3 |
Material Separation | 3 |
Device Operates Differently Than Expected | 2 |
Deflation Problem | 2 |
Material Puncture / Hole | 1 |
Inappropriate Shock | 1 |
Peeled / Delaminated | 1 |
Material Deformation | 1 |
Material Perforation | 1 |
Torn Material | 1 |
Positioning Problem | 1 |
| Total Device Problems | 213 |