Definition: A Tubular Drain Made From Silicone Or Similar Material And Is Coated With A Silver Containing Material And Is Intended To Drain Fluids From Body Cavities Using Gravity Drainage Or Attached To A Suction Pump.
| Device Type ID | 5796 |
| Device Name | Drainage Catheter With Antibiotic |
| Physical State | A Tubular Drain Made From Silicone Or Similar Material And Is Coated With A Silver Containing Material |
| Technical Method | Gravity Drainage Or Attached To A Suction Pump |
| Target Area | Normally Any Body Cavity Following Surgery |
| Regulation Description | Powered Suction Pump. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5796 |
| Device | Drainage Catheter With Antibiotic |
| Product Code | OEI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Suction Pump. |
| CFR Regulation Number | 878.4780 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bacterin International, Inc. | II | Jun-02-2014 |