PCK — Pediatric Ventricular Assist Device Class f
FDA product code PCK covers "Pediatric Ventricular Assist Device", a Class f medical device regulated under 21 CFR 870.3545. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants.
Classification Details
- Product Code
- PCK
- Device Class
- Class f
- Regulation Number
- 870.3545
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.