Device Type ID | 1884 |
Device Name | Connector, 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 1 Medical Device |
Product Code | FJQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1884 |
Device | Connector, Shunt |
Product Code | FJQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Blood Access Device And Accessories. |
CFR Regulation Number | 876.5540 [🔎] |