| Device Type ID | 1854 |
| Device Name | Needle, Fistula |
| 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 | FIE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1854 |
| Device | Needle, Fistula |
| Product Code | FIE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIMESOL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JMS NORTH AMERICA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NXSTAGE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NXSTAGE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 22 |
Device Dislodged Or Dislocated | 19 |
Disconnection | 6 |
Expulsion | 5 |
Device Issue | 4 |
Safety Interlock | 4 |
Detachment Of Device Component | 4 |
Detachment Of Device Or Device Component | 4 |
Unintended Movement | 3 |
Material Separation | 3 |
No Apparent Adverse Event | 3 |
Migration Or Expulsion Of Device | 3 |
Device Operational Issue | 2 |
Use Of Device Problem | 2 |
Occlusion Within Device | 2 |
Insufficient Information | 2 |
Dull, Blunt | 2 |
Loose Or Intermittent Connection | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Material Fragmentation | 1 |
Leak / Splash | 1 |
Backflow | 1 |
Structural Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Unintended Ejection | 1 |
Retraction Problem | 1 |
Device Operates Differently Than Expected | 1 |
Defective Component | 1 |
| Total Device Problems | 103 |