21 C.F.R. § 870.3935

Prosthetic heart valve holder.

Last amended: 2016Year: 2026Length: 61 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 870.3935 (2026)

(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]
21 C.F.R. § 870.3935: Prosthetic heart valve holder. | Justis AI