Product code NKO
- Device name
- System, Balloon, Intra-Aortic And Control, Reprocessed
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.3535
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
- Source
- FDA openFDA device classification dataset