Section 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.45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996