| Device Type ID | 2616 |
| Device Name | Catheter And Tip, Suction |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JOL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2616 |
| Device | Catheter And Tip, Suction |
| Product Code | JOL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum-powered Body Fluid Suction Apparatus. |
| CFR Regulation Number | 880.6740 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 54 |
Fluid Leak | 49 |
Leak / Splash | 39 |
Break | 35 |
Device Contamination With Chemical Or Other Material | 24 |
Material Separation | 16 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Detachment Of Device Component | 11 |
Appropriate Term/Code Not Available | 10 |
Disconnection | 8 |
Material Deformation | 7 |
Use Of Device Problem | 7 |
Packaging Problem | 6 |
Hole In Material | 5 |
Fitting Problem | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Device Inoperable | 3 |
Defective Component | 3 |
Suction Problem | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Difficult To Insert | 3 |
Loose Or Intermittent Connection | 3 |
Device Damaged Prior To Use | 3 |
Shelf Life Exceeded | 2 |
No Flow | 2 |
Contamination / Decontamination Problem | 2 |
Fracture | 2 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Failure To Adhere Or Bond | 1 |
Tip Breakage | 1 |
Failure To Advance | 1 |
Occlusion Within Device | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Kinked | 1 |
Valve(s), Failure Of | 1 |
Material Too Rigid Or Stiff | 1 |
Device Handling Problem | 1 |
Air Leak | 1 |
Complete Blockage | 1 |
Design/structure Problem | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 338 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConvaTec, Inc | II | Mar-21-2019 |
| 2 | Customed, Inc | II | Apr-14-2016 |
| 3 | Customed, Inc | II | Sep-03-2015 |
| 4 | Teleflex Medical | II | Feb-16-2019 |