| Device Type ID | 5619 |
| Device Name | Needle, Catheter |
| 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 | GCB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5619 |
| Device | Needle, Catheter |
| Product Code | GCB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 8 |
Break | 8 |
Fracture | 6 |
Detachment Of Device Or Device Component | 2 |
Needle | 1 |
Split | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Air Leak | 1 |
Material Fragmentation | 1 |
Hole In Material | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Frayed | 1 |
| Total Device Problems | 35 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Custom Healthcare Systems, Inc. | II | Jul-17-2015 |
| 2 | Pfm Medical Inc | II | Dec-12-2014 |