Definition: For Use In Hemodialysis Catheters To Reduce Hub Infection.
| Device Type ID | 2088 |
| Device Name | Hemodialysis Catheter Luer End Cap |
| Physical State | Plastic End Cap With Rod Attached |
| Technical Method | Antimicrobial Agent Adhered To Rod And Lock Ring Of End Cap. End Cap Has A Rod Which Extends Into The Hub Of The Hemodialysis Catheter To Aid In Delivering Antimicrobial Agent |
| Target Area | Implanted Blood Access Device |
| Regulation Description | Blood Access Device 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 | 876.5540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2088 |
| Device | Hemodialysis Catheter Luer End Cap |
| Product Code | PEH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PURSUIT VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 5 |
Cap | 5 |
Misassembled During Installation | 4 |
Premature Separation | 4 |
Separation Problem | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Transonic Systems Inc | II | May-09-2018 |