View all text of Subpart D [§ 870.3250 - § 870.3945]
§ 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.