| Device |
neuraxial administration set - intrathecal delivery |
| Regulation Description |
Intravascular administration set. |
| Definition |
Neuraxial Administration Sets used to deliver fluids to the intrathecal space. |
| 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 sets may include ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial connectors. |
| Target Area |
intrathecal space |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PYR |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5440
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
