Product code QLZ
- Device name
- Septostomy Catheter, Reprocessed
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5175
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To create or enlarge an atrial septal defect in the heart.
- Source
- FDA openFDA device classification dataset