21 CFR 870.3935 - Prosthetic heart valve holder.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

§ 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]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

cite as: 21 CFR 870.3935