NPG · Catheter, Infusion, Syringe
Cardiovascular · 21 CFR 870.1210 · Class 2
Overview
| Product Code | NPG |
|---|---|
| Device Name | Catheter, Infusion, Syringe |
| Regulation | 21 CFR 870.1210 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222185 | Stratus Infusion Catheter | Intervene, Inc. | Apr 13, 2023 | SESE |
Top Applicants
- Intervene, Inc. — 1 clearance
