Definition: When Used In Connection With A Locator Instrument Is Designed To Aid In The Placement Of Central Venous Catheters By Providing Real-time Information As To The Position Of The Catheter Inside The Body During The Catheter Insertion Procedure.
| Device Type ID | 2718 |
| Device Name | Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position |
| Physical State | Stainless Steel Stylet |
| Technical Method | Device Is Placed Inside A Central Venous Catheter |
| Target Area | Blood Vessels |
| Regulation Description | Percutaneous, Implanted, Long-term 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 | 880.5970 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2718 |
| Device | Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position |
| Product Code | OMF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous, Implanted, Long-term Intravascular Catheter. |
| CFR Regulation Number | 880.5970 [🔎] |