GroundRules
21 CFR 870.3935: Prosthetic heart valve holder.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 870—CARDIOVASCULAR DEVICES
- Subpart D—Cardiovascular Prosthetic Devices
(a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.
(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Collected 2026-08-27T02:24:47Z. Source file · JSON