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