| Device Type ID | 1886 |
| Device Name | Catheter, Peritoneal, Long-term Indwelling |
| Regulation Description | Peritoneal Dialysis System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FJS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1886 |
| Device | Catheter, Peritoneal, Long-term Indwelling |
| Product Code | FJS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Peritoneal Dialysis System And Accessories. |
| CFR Regulation Number | 876.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COVIDIEN, LLC | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
| Device Problems | |
|---|---|
Break | 41 |
Fluid Leak | 33 |
Catheter | 19 |
Migration Or Expulsion Of Device | 13 |
Product Quality Problem | 12 |
Defective Component | 11 |
Material Integrity Problem | 11 |
Split | 10 |
Hole In Material | 10 |
Detachment Of Device Or Device Component | 9 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Restricted Flow Rate | 8 |
Leak / Splash | 8 |
Failure To Adhere Or Bond | 6 |
Obstruction Of Flow | 5 |
Detachment Of Device Component | 5 |
Adapter (Adaptor) | 5 |
Mechanical Problem | 4 |
Crack | 4 |
Kinked | 4 |
Occlusion Within Device | 4 |
Valve | 4 |
Fracture | 3 |
Infusion Or Flow Problem | 3 |
Material Deformation | 3 |
Material Separation | 2 |
Loose Or Intermittent Connection | 2 |
Microbial Contamination Of Device | 2 |
Deformation Due To Compressive Stress | 2 |
Material Puncture / Hole | 2 |
Appropriate Term/Code Not Available | 2 |
Tip | 1 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Cuff | 1 |
Material Frayed | 1 |
Delivered As Unsterile Product | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
Contamination During Use | 1 |
Material Discolored | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Improper Flow Or Infusion | 1 |
Disconnection | 1 |
Device Damaged By Another Device | 1 |
Clamp | 1 |
| Total Device Problems | 271 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Merit Medical Systems, Inc. | II | Aug-15-2018 |
| 2 | Merit Medical Systems, Inc. | II | Mar-20-2018 |
| 3 | Pfm Medical Inc | II | Dec-12-2014 |