Product code NPG
- Device name
- Catheter, Infusion, Syringe
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1210
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To provide physician specified fluids both perivascular or intraluminal to the perivascular space.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K222185 | Stratus Infusion Catheter | Intervene, Inc. | 2023-04-13 |