Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart D - Cardiovascular Prosthetic Devices / § 870.3935 Prosthetic heart valve holder.
§ 870.3935 Prosthetic heart valve holder.
(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.