| Device Type ID | 5715 |
| Device Name | Accessories, 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) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KGZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5715 |
| Device | Accessories, Catheter |
| Product Code | KGZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Loss Of Or Failure To Bond | 54 |
Leak / Splash | 34 |
Break | 25 |
Fluid Leak | 24 |
Failure To Adhere Or Bond | 22 |
Fracture | 13 |
Crack | 12 |
Difficult To Remove | 7 |
Device Operates Differently Than Expected | 7 |
Material Separation | 5 |
Material Frayed | 4 |
Unraveled Material | 3 |
Detachment Of Device Or Device Component | 3 |
Packaging Problem | 3 |
Detachment Of Device Component | 2 |
Contamination / Decontamination Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Occlusion Within Device | 2 |
Device Dislodged Or Dislocated | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Inaccurate Flow Rate | 1 |
Defective Component | 1 |
Appropriate Term/Code Not Available | 1 |
Delamination | 1 |
Fitting Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Material Fragmentation | 1 |
Stretched | 1 |
Split | 1 |
Defective Device | 1 |
Disconnection | 1 |
Entrapment Of Device | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Device Markings / Labelling Problem | 1 |
Difficult To Advance | 1 |
| Total Device Problems | 244 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Cook Inc. | II | Mar-02-2017 |
| 3 | Cook Inc. | II | Aug-22-2016 |
| 4 | Galt Medical Corporation | II | Jul-27-2018 |
| 5 | Micromedics, Inc. | II | Apr-12-2017 |
| 6 | Vascular Solutions, Inc. | II | Jun-18-2018 |