OBK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Port, Protector/Cushion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Medical specialty
- General Hospital
- FDA definition
- Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FOAM RING PORT PROTECTOR (K062261) | Inspired Ideas, Incorporated | 2007-04-09 |
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