Definition: The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
| Device Type ID | 2748 |
| Device Name | Midline Catheter |
| Physical State | Consists Of A Thin, Flexible Plastic Tube That May Have A Guide Wire Inside The Catheter To Add Stiffness To Facilitate Insertion |
| Technical Method | The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications. |
| Target Area | The Catheter Is Inserted In The Peripheral Vascular System (basilic, Cephalic, Or Brachial Veins) Usually Above The Antecubital Fossa And The Tip Terminates At Or Near The Axillary Area. |
| Regulation Description | Intravascular Catheter. |
| 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 | 880.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PND |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2748 |
| Device | Midline Catheter |
| Product Code | PND |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Catheter. |
| CFR Regulation Number | 880.5200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PFM MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VYGON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Difficult To Remove | 1 |
| Total Device Problems | 1 |