§ 870.3935. Prosthetic heart valve holder.
61 words·~1 min read·
/us/cfr/t21/s§ 870.3935·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]