| Device Type ID | 5618 |
| Device Name | Catheter, Cholangiography |
| 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 | GBZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5618 |
| Device | Catheter, Cholangiography |
| Product Code | GBZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 9 |
Device Contamination With Chemical Or Other Material | 5 |
Misassembled | 5 |
Unraveled Material | 3 |
Break | 3 |
Fluid Leak | 3 |
Split | 2 |
Device Markings / Labelling Problem | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Product Quality Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Physical Resistance | 1 |
Device Operates Differently Than Expected | 1 |
Material Integrity Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Occlusion Within Device | 1 |
Component Missing | 1 |
Structural Problem | 1 |
Catheter | 1 |
Material Deformation | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Sticking | 1 |
Folded | 1 |
Material Protrusion / Extrusion | 1 |
Complete Blockage | 1 |
Material Fragmentation | 1 |
Unsealed Device Packaging | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Needle | 1 |
Insufficient Information | 1 |
Device Slipped | 1 |
Material Perforation | 1 |
Crack | 1 |
| Total Device Problems | 62 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Catheter Corp | II | Jul-22-2015 |
| 2 | Atrium Medical Corporation | II | Dec-06-2018 |
| 3 | Atrium Medical Corporation | II | Feb-16-2017 |
| 4 | Atrium Medical Corporation | II | Nov-16-2016 |
| 5 | Atrium Medical Corporation | II | Aug-05-2015 |
| 6 | Cook Inc. | II | Jul-18-2015 |
| 7 | Teleflex Medical | II | Jun-12-2014 |