Product code OBK
- Device name
- Port, Protector/Cushion
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5965
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
- Source
- FDA openFDA device classification dataset