Product code PFJ
- Device name
- Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4260
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- Mechanical dilation of the cervical canal for labor.
- Source
- FDA openFDA device classification dataset