Definition: Peripheral Catheter Monitor (PIV) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations.
| Device Type ID | 2747 |
| Device Name | Peripheral Intravenous (piv) Infiltration Monitor |
| Physical State | The Device Consists Of A Monitor, A Reusable Optical Sensor Cable And A Single-use Sensor Receptacle. |
| Technical Method | The Peripheral Intravenous (PIV) Monitoring Device That Uses Visible And Near-infrared Light To Measure Changes In The Optical Properties Of The Tissue Near A PIV Insertion Site To Determine If An Infiltration Of The Peripheral Catheter Has Occurred. |
| Target Area | Peripherally-inserted IVs (PIVs), Generally On The Forearm Or Dorsal Aspect Of The Hand. |
| Regulation Description | Infusion Pump. |
| 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 | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PMS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2747 |
| Device | Peripheral Intravenous (piv) Infiltration Monitor |
| Product Code | PMS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IVWATCH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |