OPR — Intrasaccular Flow Disruption Device Class III
FDA product code OPR covers "Intrasaccular Flow Disruption Device", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- OPR
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.