Definition: Neuraxial Administration Sets Used To Deliver Fluids To The Intrathecal Space.
| Device Type ID | 2789 |
| Device Name | Neuraxial Administration Set - Intrathecal Delivery |
| Physical State | Administration Sets Are Made Of Polymers And Connected To Infusion Pumps Or Medication Containers Such As Syringes Or Flexible Medication Containers. |
| Technical Method | Administration Sets Are Made Of Polymers, Are Connected To Infusion Pumps Or Medication Containers (i.e. Syringes, Flexible Medication Containers), And Are Used To Deliver Fluids From The Storage Container Or Pump Into The Intrathecal Space. These Se |
| Target Area | Intrathecal Space |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PYR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2789 |
| Device | Neuraxial Administration Set - Intrathecal Delivery |
| Product Code | PYR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |