Definition: To Assist In The Removal Of Tunneled Long Term Catheter Cuffs Using A Minimal Invasive Technique By Seperating The Tissue Ingrowth Cuff From The Surrounding Tissue. Following Seperation Of The Cuff From The Tissue, The Catheter Can Be Safely Removed
| Device Type ID | 2711 |
| Device Name | Tunneled Catheter Remover |
| Physical State | The Device Is Made Of A Rigid Or Semirigid Material And Is Designed To Be Able To Snap Over The Catheter Body. The Deivce May Have A Hinge Or Handle To Assist In Holding The Device And Manipulating The Removal Function During Operation. |
| Technical Method | The Device Is Designed To Snap Over A Catheter Body And To Be Guided Over The Cather Through The Insertion Site And Into The Subcutaneous Tissue Where The Catheter Tissue Cuff Is Adhering To The Tissue. The User Of The Catheter Removal Device, With A |
| Target Area | Tunneled Catheters With Tissue Ingrowth Cuffs. |
| 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 | ODY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2711 |
| Device | Tunneled Catheter Remover |
| Product Code | ODY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous, Implanted, Long-term Intravascular Catheter. |
| CFR Regulation Number | 880.5970 [🔎] |