Device Type ID | 1864 |
Device Name | Cannula, A-v Shunt |
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 3 Medical Device |
Product Code | FIQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1864 |
Device | Cannula, A-v Shunt |
Product Code | FIQ |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Blood Access Device And Accessories. |
CFR Regulation Number | 876.5540 [🔎] |
Device Problems | |
---|---|
Fluid Leak | 1 |
Total Device Problems | 1 |