OZH — Transcatheter Septal Occluder (Ventricular) Class III

FDA Device Classification

FDA product code OZH covers "Transcatheter Septal Occluder (Ventricular)", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
OZH
Device Class
Class III
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

Definition

For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique.