PYX — Temporary Non-Roller Type Right Heart Support Blood Pump Class III
FDA product code PYX covers "Temporary Non-Roller Type Right Heart Support Blood Pump", a Class III medical device regulated under 21 CFR 870.4360. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- PYX
- Device Class
- Class III
- Regulation Number
- 870.4360
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Providing temporary partial or full right heart circulatory support.