Product code OKC
- Device name
- Implanted Subcutaneous Securement Catheter
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5970
- Review panel
- HO
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.
- Source
- FDA openFDA device classification dataset