OEI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Drainage Catheter With Antibiotic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| ELUTIA COATED CLOSED SURGICAL WOUND DRAIN (K063245) | Bacterin International, Inc. | 2007-11-28 |
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