Product code QTF
- Device name
- Reprocessed Atherectomy Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4875
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
- Source
- FDA openFDA device classification dataset