Definition: Intended To Cushion And Protect The Localized Area Surrounding The Implanted Port And Indicated For Subjects Having Implanted Subcutaneous Or Intravascular Infusion Ports.
| Device Type ID | 2708 |
| Device Name | Port, Protector/cushion |
| Physical State | Device Is A Foam Ring With Adhesive That Is Placed On Intact Skin Over The Port Access Site. The Foam Ring Can Be Any Defined Shape That Covers The Port. The Foam Provides A Barrier To The Implanted Port. |
| Technical Method | Device Is Applied On Top Of Intact Skin And Provides A Protection Barrier Over The Implanted Port. |
| Target Area | The Device Is Used On Intact Skin. |
| Regulation Description | Subcutaneous, Implanted, Intravascular Infusion Port And 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 | 880.5965 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2708 |
| Device | Port, Protector/cushion |
| Product Code | OBK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Subcutaneous, Implanted, Intravascular Infusion Port And Catheter. |
| CFR Regulation Number | 880.5965 [🔎] |